HumanaCommercial Clinical Policy

Humana Bone Graft Substitutes - Medicare Advantage Form


Bone Graft Substitutes

Notes: Specific products and manufacturers should be referenced within the provided list of allograft products to confirm coverage.

Indications

(175722) Is the bone graft material either an autograft or allograft? 
(175723) Is the use of the bone graft substitute intended for enhancement of bone healing? 
(175724) Is the bone graft substitute being utilized according to the FDA-approved marketing label indications effective on the date of service? 

Contraindications

(175725) Is the bone graft substitute intended for non-medical necessary services, aesthetic purposes, or unrelated to the diagnosis or treatment of illness, injury, or malformed body member? 
(175726) Does the use of the bone graft substitute relate to dental services in connection with the care, treatment, filling, removal, or replacement of structures directly supporting teeth, not including reconstruction of a dental ridge performed because of and at the same time as the surgical removal of a tumor? 
YesNoN/A
YesNoN/A

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Effective Date

01/01/2024

Last Reviewed

NA

Original Document

  Reference



Related Medicare Advantage Medical/Pharmacy Coverage Policies

Platelet-Derived Growth Factors for Wound Healing

Related Documents

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/ Transmittals.

Bone Graft Substitutes Page: 2 of 35

Description

Bone grafts may be used in the treatment of delayed fracture unions, in spinal fusions, to bridge major bone defects or fill cavities created by tumor removal, cysts or other causes. Bone graft material may come from a number of sources: autograft (the individual’s own bones), allograft (a bone bank), demineralized bone matrix or bone graft substitutes, such as synthetic materials, ceramics (bone void fillers), collagen composites, composite cement materials, bone morphogenetic protein or recombinant human bone morphogenetic protein.

Autograft Autograft is considered the gold standard for bone grafting and is taken directly from the individual. The usual site for an autograft harvest is the posterior iliac crest. When autograft material is of an insufficient volume, of poor quality or cannot be used for any other reason, another type of material must be used for the bone graft. NOTE: In the context of this policy, blood products (including platelets) and bone marrow aspirate (including mesenchymal stem cells) are NOT considered autograft materials.

Allograft Allograft is obtained from cadaveric bone and/or tissue from a bone bank and may be used alone or in combination with another material. Even when used alone, allograft must be processed to decrease the likelihood of disease transmission and immunogenic response. NOTE: In the context of this policy, amniotic membrane/placental membrane, blood products (including platelets) and bone marrow aspirate (including mesenchymal stem cells) are NOT considered allograft materials.

Bone Morphogenetic Proteins and Recombinant Human Bone Morphogenetic Proteins Bone morphogenetic proteins (BMP) are naturally occurring proteins found in human bone and play an active role in bone formation. There are currently fourteen BMPs that have been identified. In addition to the fourteen BMPs, there are several recombinant human bone morphogenetic proteins (rhBMPs).

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Currently there are only two which have been developed for use: rhBMP-2 and rhBMP-7 (it should be noted, however, that rhBMP-7 is no longer marketed or available in the United States).rhBMPs serve as alternatives or adjuncts to autologous bone grafts (autografts). They are intended to promote bone formation and enhance fracture healing175 and may be used in spinal fusion surgery for degenerative disease to promote bone growth that results in fusion.168 These proteins may also be used for an individual who has up to grade I spondylolisthesis. rhBMPs have been proven safe in L2 (second lumbar vertebra) through S1 (sacral) levels of the spine. Severe life threatening complications have been associated with cervical spine use.168 Another major application of bone grafting with rhBMP is for bone repair, especially for treatment of delayed union of tibial fractures.175 rhBMP also plays a role in cartilage formation and repair of other musculoskeletal tissues.The rhBMP needs to stay in the region of repair to influence skeletal formation (healing). In order for this to happen, the rhBMPs must be utilized with a suitable carrier. One of the most common carriers is a collagen sponge.

Ceramics/Bone Void Fillers Ceramics are synthetically produced bone void fillers. As a conductive technology, ceramics are synthetic materials resulting from heating up chemically formed compounds that consequently bond together. There are many different methods to produce ceramics and numerous chemical compounds that can be combined, including calcium phosphate, calcium sulfate-calcium composite, beta tricalcium phosphate or nanocrystalline hydroxyapatite.

Demineralized Bone Matrix Demineralized bone matrix (DBM) is a type of allograft that is produced by acid extraction of allograft bone, known as decalcification.

Based on manufacturing techniques, DBM may be a freeze-dried powder, granules, gel, putty or strips.

Combination Bone Graft Substitutes

A newer practice in bone graft substitutes is the combination of different materials to produce a completely different product, with the theory that each different property working together will aid in the healing and grafting process.

NOTE: This classification (combination bone graft substitutes) does not refer to the practice of combining autograft or allograft bone with a bone void filler or DBM, but rather combining different bone graft substitute products.

Coverage Determination

Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria.

The following bone graft materials/bone graft substitute products will be considered medically reasonable and necessary when the following requirements are met AND utilized according to the FDA-approved marketing label indications effective on the date of service:

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  • Vikos Void Filler
  • Calcium Phosphate Ceramic/Bone Void Fillers Examples include, but may not be limited to:
    • AccuFill
    • Actifuse
    • Arthrex Quickset
    • HydroSet XT
    • OsteoVation
    • OsteoVation EX
    • Norian Drillable
    • Venado
  • Calcium Sulfate-Calcium Composite Ceramics/Bone Void Fillers Examples include, but may not be limited to:
    • Altapore
    • Altapore Shape
    • Calcigen S
    • InterSep
    • OsteoSet
    • OsteoVation QWIK
    • Pro-Dense
    • Stimulan
  • Demineralized Bone Matrix (DBM) Examples include, but may not be limited to:
    • 3D ProFuse
    • 3-Demin
    • Accell Connexus
    • Accell EVO3c
    • Accell Total Bone Matrix
    • AlloFlex Plus
    • AlloFuse
    • Allomatrix
    • AlloSync
    • AlphaGraft DBM
    • Apex
    • Ballast
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CRITERIA/INDICATIONS FOR COVERAGE

  • DYINE UNA T WEATENALO/SUDOITIITVUIE PAY ULS
    • Reficio
    • StaGraft Cancellous DBM Sponge
    • StaGraft Cancellous DBM Strip
    • StaGraft Fiber
    • Sterifuse DBM Putty; Sterifuse Crunch
    • StimuBlast
    • SXDBM
    • SXDBM Fiber
    • TENSIX
    • Vega Graft
    • Vesuvius DBM (DBM Putty; DBM Putty 100; Demineralized Fibers; Demineralized Sponge)
    • VIA Form
    • VIA Graft
    • ViviGen
    • DBM
  • Xemplifi
  • Recombinant Human Bone Morphogenetic Proteins (rhBMP)
    • INFUSE Bone Graft (rhBMP-2)
  • Recombinant Human Bone Morphogenetic Proteins (rhBMP)
    • INFUSE Bone Graft/LT-CAGE Lumbar Tampered Fusion Device (with titanium cage) (rhBMP-2)

This product may ONLY be approved when used with 1 of the 8 cages approved for use with INFUSE by the FDA.

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Absence of contraindications; AND

ONLY for a SINGLE-LEVEL lumbar fusion surgery when lumbar fusion criteria are met; AND

Used in combination with 1 of the following:

  • Clydesdale Spinal System — single level fusion, L2-L5 vertebra, via an oblique lateral interbody fusion (OLIF) approach; OR
  • Divergence-L Anterior/Oblique Lumbar Fusion System: Single level fusion, L2-S1 vertebra, via an anterior lumbar interbody fusion (ALIF) approach; OR Single level fusion, L5-S1 vertebra, via an OLIF approach; OR
  • INTER FIX RP Threaded Fusion Device – single level lumbar fusion, via an open anterior approach; OR
Bone Graft Substitutes Page: 8 of 35
BONE GRAFT MATERIALS/SUBSTITUTE PRODUCTSCRITERIA/INDICATIONS FOR COVERAGE
Pivox Oblique Lateral Spinal System — single level fusion, L2-L5 vertebra, via an OLIF approach

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

No payment may be made for dental services in connection with care, treatment filling, removal or replacement of structures directly supporting teeth, except for the reconstruction of a dental ridge performed because of and at the same time as the surgical removal of a tumor.

The use of INFUSE Bone Graft (rhBMP-2) and/or INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device (rhBMP-2) will not be considered medically reasonable and necessary for the following:

  • Cervical spinal fusion; OR
  • Combined with a carrier other than collagen or with a fusion device other than a cage; OR
  • Craniofacial applications including sinus augmentation and/or alveolar ridge augmentation; OR
  • Multilevel lumbar fusion, regardless of surgical approach; OR
  • Nonanterior or nonoblique lateral interbody fusion approaches to lumbar fusion; OR
  • Primary treatment of closed tibial fractures; OR
  • Thoracic spinal fusion; OR
  • Treatment of delayed union or nonunion of tibial fracture as part of a planned, staged reconstruction; OR
  • Use of INFUSE Bone Graft/LT-CAGE Lumbar Tampered Fusion Device (rhBMP-2) with non-FDA approved spinal cages

A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.

Contraindications to the use of INFUSE Bone Graft (rhBMP-2) and/or INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device include the following:

  • Active infection at the operative site; OR
  • Active malignancy; OR
  • Compartment syndrome of the affected limb; OR
  • Inadequate neurovascular status; OR
  • Known hypersensitivity to bovine Type I collagen, rhBMP-2 or other components of the formulation; OR
  • Pregnancy; OR
  • Skeletally immature (18 years of age or younger, or have no radiographic evidence of epiphyseal closure); OR
  • Utilization in the vicinity of a resected or extant tumor

A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment.

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There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.

Bone Graft Substitutes Page: 10 of 35

Percutaneous injection of calcium-based biodegradable osteoconductive material (proximal femur, including imaging guidance, unilateral) will not be considered medically reasonable and necessary. A review of the current medical literature shows that there is no evidence to determine that this service is standard medical treatment. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.

The use of any of the following bone graft substitute products will not be considered medically reasonable and necessary for ANY indication:

BONE GRAFT MATERIALS/SUBSTITUTE PRODUCT

PURPORTED USE (NOT COVERED FOR ANY INDICATION)

Augment (including, but not limited to, Augment Injectable)Comprised of beta tricalcium phosphate and recombinant human platelet derived growth factor (rhPDGF).
(red blood cells [RBC], white blood cells [WBC], whole blood) including, but not limited to, nSTRIDE Autologous Protein Solution (APS)component is extracted; it is then either injected into a joint (proposed as a treatment for osteoarthritis) or injured tendon, or is mixed with/combined with a bone graft substitute product.
Beta Tricalcium Phosphate Bone Void Fillers Examples include, but may not be limited to:A synthetically produced bone graft material/ substitute; falls under the broad category ceramics/bone void fillers. Proposed for use as a bone graft substitute or bone graft extender to fill in and promote healing of bone voids or gaps in the skeletal system.
Examples include, but may not be limited to: Allogran-R, BoneSync, ChronOS, Collage, Integra Mozaik, IsoTis Mozaik, Matriform SI, OSferion, OsteoStrux, OsSatura TCP, OsteoVation B-TCP, Vitoss 
Bioactive Glass Examples include, but may not be limited to:Unlike window or household glass, bioactive glass has a different chemical composition (calcium-phosphorus-sodium-silicate) and is reactive to extracellular fluids and therefore bonds to bone. Due to this reaction, it is purported that the glass will release substances that are biocompatible and activate a mechanism that promotes
Examples include, but may not be limited to: Bi-Ostetic Bioactive Glass, BioSphere Flex, BioSphere Putty, BonAlive 
  • Autologous Blood Product Injection (red blood cells [RBC], white blood cells [WBC], whole blood) including, but not limited to, nSTRIDE Autologous Protein Solution (APS)
  • Beta Tricalcium Phosphate Bone Void Fillers Examples include, but may not be limited to:
    • Allogran-R
    • BoneSync
    • ChronOS
    • Collage
    • Integra Mozaik
    • IsoTis Mozaik
    • Matriform SI
    • OSferion
    • OsteoStrux
    • OsSatura TCP
    • OsteoVation Β-TCP
    • Vitoss
  • Bioactive Glass Examples include, but may not be limited to:
    • Bi-Ostetic Bioactive Glass
    • BioSphere Flex
    • BioSphere Putty
    • BonAlive
    • FIBERGRAFT BG Morsels
    Bone Graft Substitutes Page: 11 of 35
    PRODUCT(NOT COVERED FOR ANY INDICATION)
    FIBERGRAFT BG Putty, Interface NovaBone Morsels, OssiMend (Strips, Blocks, Putty), PURbridge, Signal Bioactive Fibers, Signify, Tornado Bioactive, Vitoss BA, Vitoss BiModalnew bone growth.

    Over time, the glass dissolves completely and is replaced by bone tissue. Proposed for use in bony voids or gaps of the skeletal system (posterolateral spine, extremities and pelvis).

    Bone Marrow Aspirate (BMA) Mixing an individual's bone marrow aspirate with the bone graft substitute, rather than blood or autologous bone; or injection of BMA into a joint, intervertebral disc, ligament/tendon or other structure.

    NOT COVERED for ANY orthopedic applications including, but may not be limited to:

    • As an adjunct to a spinal fusion; OR
    • Bone cysts; OR
    • Degenerative disc disease; OR
    • Nonunion fractures; OR
    • Osteoarthritis; OR
    • Repair or regeneration of musculoskeletal tissue (including intervertebral disc); OR
    • When mixed with any bone graft substitute

    Cell-Based Substitutes Examples include, but may not be limited to:

    • AmnioFix
    • Amniovo
    • Arthrex Amnion Matrix & Viscous
    • Bio4 Viable Bone Matrix
    • BioDFactor
    • BioDFence
    • BioDRestore
    • BioD Dry Flex
    • Cygnus
    • ENHANCE Amnion
    • NuCel
    • Osteocel Plus
    • Osteocel Pro
    • OsteoVive Plus
    • PalinGen
    • Regenexx
    • ReNu
    • Stravix
    • Trinity Elite

    Bone Graft Substitutes Page: 12 of 35

    BONE GRAFT MATERIALS/SUBSTITUTE PRODUCT

    PURPORTED USE (NOT COVERED FOR ANY INDICATION)

    PRODUCT e Trinity Evolution e ViaCell e Viaflow

    (NOT COVERED FOR ANY INDICATION)

    e Viaflow C Combination Bone Graft Substitute

    Beta tricalcium phosphate combined with bioactive glass

    Proposed for use in orthopedic surgery for filling osteochondral defects. Beta tricalcium phosphate combined with bioactive glass

    Examples include, but may not be limited to:

    • SignaFuse Bioactive Bone Graft Putty
    • SignaFuse Bioactive Bone Graft Strip

    and hydroxyapatite Proposed for use in bony voids or gaps of the skeletal system (posterolateral spine, extremities and pelvis).

    Combination Bone Graft Substitute e genex

    Beta tricalcium phosphate combined with calcium sulfate Proposed for use in bony voids and defects that are not intrinsic to structural stability. Beta tricalcium phosphate combined with hydroxyapatite (may also be referred to as a biphasic calcium phosphate) Proposed for use in bony voids or gaps of the skeletal system (posterolateral spine, extremities and pelvis).

    Combination Bone Graft Substitutes Examples include, but may not be limited to:

    • Amplify
    • AttraX Putty/Scaffold
    • Bi-Ostetic Bicera Eclipse Granules/Putty
    • MagnetOs
    • Mastergraft (granules, strip or putty)
    • Montage Bone Putty
    • OsteoMatrix+
    • Osteon
    • VENADO Foam Strip/Granules

    Combination Bone Graft Substitute

    Beta tricalcium phosphate combined with magnesium

    e@ OSTEOREVIVE

    oxide Proposed for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to

    Combination Bone Graft Substitute Examples include, but may not be limited to:

    • BoneSync BioActive
    • Contour BA
    • Opus BA Bioactive strip

    Proposed for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure.

    Bioactive glass combined with carbonate apatite anorganic bone mineral and Type 1 collagen Proposed for use in bony voids or gaps of the skeletal system (extremities, pelvis and spine).

    Bone Graft Substitutes Page: 13 of 35
    PRODUCT(NOT COVERED FOR ANY INDICATION)
    e OssiMend Bioactive e VIA Mend
    Combination Bone Graft SubstitutesBioactive glass combined with hyaluronic acid and
    Examples include, but may not be limited to Kinex Bioactivecollagen
    e e Kinex Plus BioactiveProposed for use in bony voids or gaps of the skeletal system (extremities, pelvis and spine).
    Combination Bone Graft SubstituteCalcium phosphate combined with hyaluronic acid
    e TactosetProposed for filling bone voids or defects of the skeletal system (extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.
    Combination Bone Graft SubstituteCombination polymer (PLGA) with hyaluronic acid
    e InQuProposed for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the spine when combined with bone autograft.
    Combination Bone Graft Substitute Examples include, but may not be limited to:e NanoFUSE Bioactive Matrix e NanoFUSE putty, strips
    DBM combined with bioactive glass Proposed for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the posterolateral spine when combined with bone autograft.
    Combination Bone Graft Substitute Examples include, but may not be limited to:e Allomatrix C e Allomatrix Custom
    DBM combined with calcium sulfate Proposed for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. DBM combined with ceramic bone void filler
    Examples include, but may not be limited to:e InterGro DBM Plus
    Proposed for filling bony voids or gaps in the extremities

    Combination Bone Graft Substitutes Examples include, but may not be limited to:

    • StaGraft DBM Putty
    • StaGraft DBM PLUS

    Combination Bone Graft Substitute

    Proposed for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. DBM combined with hydroxyapatite and calcium carbonate Proposed for use in bone voids and gaps in the extremities or pelvis that is not intrinsic to the stability of the structure.

    Bone Graft Substitutes Page: 14 of 35
    PRODUCT(NOT COVERED FOR ANY INDICATION)
    e EquivaBoneProposed for use as bone void fillers of the pelvis, extremities and the posterolateral spine.
    Combination Bone Graft SubstituteHydroxyapatite combined with beta tricalcium phosphate
    e OsteoFlo NanoPuttybioactive glass and alpha tricalcium phosphate (may also be referred to as quadphasic synthetic bone graft)
    Proposed for bony voids or gaps of the skeletal system (extremities and pelvis) not intrinsic to the stability of the
    Examples include, but may not be limited to:e Pro Osteon 200R e Pro Osteon 500R Proposed for filling bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone.
    e Cerament e Cerament GProposed for use in bony voids or gaps of the skeletal
    Combination Graft Substitutessystem (posterolateral spine, extremities and pelvis). combined with
    BoneNanocrystalline hydroxycarbonoapatite
    Examples include, but may not be limited to:e Agilon Moldable calcium carbonate
    e Aglion Strip e OsteoSpan e Morpheus Combination Bone Graft SubstituteProposed for bony voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (the extremities, posterolateral spine and pelvis). Tricalcium phosphate combined with hydroxyapatite
    Examples include, but may not be limited to:e Current e OsteoCurrent
    i-FACTOR Peptide Enhanced Bone GraftComposite material consisting of a synthetic peptide (P-15) adsorbed onto calcium phosphate particles, suspended in a hydrogel carrier.

    INFUSE/MASTERGRAFT (rhBMP-2) Proposed for single level anterior cervical spinal fusion. Combination rhBMP-2 and Mastergraft granules (beta tricalcium phosphate and hydroxyapatite).

    Nanocrystalline Hydroxyapatite Examples include, but may not be limited to:

    Proposed for use in posterolateral spinal fusion at two or more levels for pseudoarthrodesis. A synthetically produced bone graft material/ substitute that is a specific type of ceramic/bone void filler. It consists of a calcium phosphate that has been subjected to additional structural process, which changes the particle size.

    Bone Graft Substitutes Page: 15 of 35
    e Beta-BSM Injectable e Cem-Ostetic e Gamma-BSM moldable puttyconsists of a calcium phosphate that has been subjected to additional structural process, which changes the particle size.
    e N-Force Blue e NanoBone e NanOssProposed for bony voids or gaps that are not intrinsic to the stability of bony structure.
    Platelet Rich Plasma (PRP)PRP, which is harvested from an individual’s own blood, has been proposed as a treatment to accelerate healing of tendon/ligament injuries or aid in bone healing or grafting.

    PRP is prepared by obtaining a small amount of the individual’s blood, which is then centrifuged to separate the platelets from the other components found in blood. PRP is NOT covered for ANY indication including, but may not be limited to:

    • Bone healing and fusion; OR
    • Joint pain or repair; OR
    • Ligament or tendon injuries; OR
    • Osteoarthritis; OR
    • Soft tissue injuries; OR
    • Used in combination with ANY bone graft substitute product

    Examples include, but may not be limited to:

    • ATEC Neocore
    • CopiOs Bone Void Filler Paste
    • CopiOs Bone Void Filler Sponge
    • FIBERGRAFT BG Matrix
    • Grafton DBF
    • Ignite
    • Influx
    • Mastergraft Matrix EXT
    • Mastergraft Strip
    • PLATFORM CM
    • Sorrento
    • ViaSorb

    A review of the current medical literature shows new bone regeneration. Proposed for bony voids or gaps that are not intrinsic to the stability of bony structure. that the evidence is insufficient to determine that this service is standard medical treatment.

    There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.