Anthem Blue Cross Connecticut Commercial Clinical Policy

Anthem Blue Cross Connecticut SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting Form

Effective Date

12/28/2023

Last Reviewed

02/16/2023

Original Document

  Reference



This document addresses the use of soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures. There is a wide array of uses for such products, including use as a cover for wounds related to disease processes (e.g., diabetes, peripheral artery and venous disease, recessive dystrophic epidermolysis bullosa), coverage or support of surgical and other wounds (e.g., complex abdominal wall repair, breast, and other types of reconstructive procedures), use as a surgical reconstructive material during surgical procedures (e.g., ligament augmentation or substitution, slings for internal organs, trauma, fistula repair, congenital defects), structural support of soft tissues (e.g., injection laryngoplasty, cosmetic augmentation), treatment for dermal and other burns, use in nerve grafting procedures, and many others. Tissue-engineered skin is a significant advance in the field of wound healing and was developed due to limitations associated with the use of autografts.

For the purposes of this document the following terms are defined as below:

  • Autologous: A product derived from the individual’s own body or body products.
  • Allogeneic: A product derived from humans, other than the individuals themselves.
  • Xenographic: A product derived from non-human organisms (e.g., cows, pigs, horses, etc.).
  • Synthetic: A product derived from man-made materials.
  • Composite: A product derived from a mix of materials of various origins.
  • Bioengineered: A product derived from cultured and processed autologous cells

Note: The use of fresh, unfrozen, unprocessed allogeneic cadaver-derived skin grafts is not addressed in this document.

Note: This document does not address the use of meshes or patches of non-biologic origin when used for standard hernia repair procedures.

Note: This document does not address products used to treat osteochondral defects.

Note: For additional information please see:

  • ANC.00007 Cosmetic and Reconstructive Services: Skin Related
  • ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck
  • MED.00110 Silver-based Products for Wound and Soft Tissue Applications
  • MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures
  • SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures
  • TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Position Statement

Medically Necessary:

I. Breast reconstruction surgery

The following products are considered medically necessary when used for breast reconstruction surgery:

  1. AlloDerm Regenerative Tissue Matrix (aseptic or sterile); or
  2. DermACELL™; or
  3. DermaMatrix®; or
  4. FlexHD®; or
  5. SimpliDerm™; or
  6. Strattice™.

II. Burns

The following products are considered medically necessary when used for the treatment of full-thickness or deep partial-thickness burns:

  1. Biobrane; or
  2. EZ Derm™; or
  3. Fresh frozen unprocessed allograft skin products (for example, AlloSkin™*, TheraSkin®); or
  4. Integra™ Bilayer Matrix Wound Dressing; or
  5. StrataGraft®

*Note: “AlloSkin”, “AlloSkin RT™”, and “Alloskin™ AC” are different products. AlloSkin is a fresh-frozen product, AlloSkin RT is a fresh irradiated product (not frozen) and Alloskin AC is an acellular dermal matrix product. Please see the investigational and not medically necessary section below for the position on AlloSkin RT™ and Alloskin™ AC.

III. Complex abdominal wall wounds

The following products are considered medically necessary for the surgical repair of complex abdominal wall wounds:

  1. AlloDerm Regenerative Tissue Matrix (aseptic or sterile); or
  2. Strattice; or
  3. OviTex™.

IV. Diabetic foot ulcers

The following products are considered medically necessary for the treatment of diabetic foot ulcers when the clinical criteria below have been met:

  1. Products:
    1. AmnioBand®, sheet or membrane form; or
    2. Apligraf®; or
    3. DermACELL™; or
    4. Dermagraft®; or
    5. EpiCord; or
    6. EpiFix™; or
    7. Grafix® PRIME; or
    8. Kerecis®; or
    9. mVASC; or
    10. TheraSkin®;
      and
  2. Clinical Criteria:
    1. Ulcers that have not healed with standard conservative therapy (such as surgical debridement, complete off-loading, and standard dressing changes) attempted for at least 1 month but not greater than 52 weeks.

V. Dystrophic epidermolysis bullosa

The following products are considered medically necessary for the treatment dystrophic epidermolysis bullosa:

  1. Dermagraft®; or
  2. OrCel™.

VI. Lower extremity dermal wounds

The following products are considered medically necessary for the treatment of lower extremity dermal wounds when the clinical criteria below have been met:

  1. Products:
    1. GraftJacket™, sheet or membrane form; or
    2. Oasis™; or
    3. PriMatrix™; or
    4. TheraSkin;
      and
  2. Clinical Criteria:
    1. Wounds that have not healed with standard conservative therapy (such as surgical debridement, complete off-loading, standard dressing changes, and compression therapy) attempted for at least 1 month but not greater than 52 weeks.

VII. Ocular indications

Allogeneic amniotic membrane-derived grafts or wound coverings, including, but not limited to the following, are considered medically necessary when the clinical criteria below have been met:

  1. Products:
    1. AmbioDisk™; or
    2. AmnioGraft®; or
    3. Artacent® Ocular; or
    4. Prokera®; or
    5. Vendaje Optic™*;
      and
  2. Clinical Criteria:
    1. Reconstruction of large conjunctival resections; or
    2. Treatment of corneal injuries; or
    3. As an adjunct to surgical procedures involving the cornea.

*See Investigational and Not Medically necessary section for the use of other Vendaje products.

VIII. Venous stasis ulcers

The following products are considered medically necessary for the treatment of chronic venous stasis ulcers when the clinical criteria are met:

  1. Products:
    1. AmnioBand, sheet or membrane form; or
    2. Apligraf®; or
    3. EpiFix™;
      and
  2. Clinical Criteria:
    1. Wound has been present for at least 1 month; and
    2. Has been unsuccessfully treated with compression therapy for at least 14 days.

Not Medically Necessary:

The following products are considered not medically necessary when criteria above are not met and for any use not listed above:

  • AlloDerm Regenerative Tissue Matrix (aseptic or sterile)
  • Allogeneic amniotic membrane-derived grafts or wound coverings when used for ocular indications
  • AlloSkin
  • AmbioDisk
  • AmnioBand, sheet or membrane form
  • AmnioGraft
  • Apligraf
  • Artacent Ocular
  • Biobrane
  • DermACELL
  • Dermagraft
  • DermaMatrix
  • EpiCord
  • EpiFix, sheet or membrane form
  • EZ Derm
  • FlexHD
  • Fresh frozen unprocessed allograft skin products (for example, AlloSkin*, TheraSkin)
  • Grafix PRIME
  • GraftJacket, sheet or membrane form
  • Integra Bilayer Matrix Wound Dressing
  • Kerecis™
  • mVASC
  • Oasis
  • OrCel
  • OviTex
  • PriMatrix
  • Prokera
  • SimpliDerm
  • StrataGraft
  • Strattice
  • TheraSkin
  • Vendaje Optic

Investigational and Not Medically Necessary

The use of all other allogeneic, xenographic, synthetic, and composite products for wound healing or soft tissue grafting, including but not limited to the following products, is considered investigational and not medically necessary for all uses:

  • Actishield™
  • ActiveBarrier®
  • ActiveMatrix®
  • ACM Surgical Collagen
  • ACM Extra Surgical Collagen
  • ACM Extra Surgical Collagen Powder
  • Affinity™
  • AlloGen-LI™ 
  • AlloGen™ 
  • AlloMax™
  • AlloMend™
  • Allopatch HD™
  • AlloPatch® Pliable
  • Alloskin AC
  • AlloSkin RT
  • AlloWrap®
  • AlloWrap™ Dry
  • AlloWrap™ DS
  • Alphaplex™ with MariGen Omega3™
  • AltiPly™
  • AmbientFactor™
  • Ambio5®
  • AmnioBind
  • AmnioCore
  • Amnio F™
  • Amnio FRT™
  • AmnioGuard®
  • Amnio Restore™
  • Amnio wound
  • AmnioAMP-MP
  • AmnioAMP-PF
  • AmnioAMP-X
  • AmnioArmor®
  • AmnioBand, particulate or injectable form
  • AmnioCare®
  • AmnioClear®
  • AmnioCord®
  • AmnioCyte
  • AMNIOEXCEL™
  • Amniofill®
  • AmnioFix™
  • Amnioflex™
  • AmnioHeal®
  • AmnioMatrix™
  • AmnioMTM™
  • Amniopro™
  • AMNIOREPAIR™
  • Amnios®
  • Amnios® RT
  • AmnioShield®
  • Amniostrip™
  • Amniotext
  • Amniovo™ (Solo, Dual, and Matrix)
  • Amniovo™ Max
  • Amniowrap2™
  • Amniply
  • AmnyoFactor™
  • AmnyoFluid™
  • Anu RHEO™
  • Aongen™ Collagen Matrix
  • Apis®
  • Architect Extracellular Matrix™
  • AROA ECM™
  • Artacent® AC Powder
  • Artacent® cord
  • Artacent® Flex
  • Artacent® Wound
  • Artelon®
  • Arthrex® Amnion matrix
  • ArthroFlex™
  • ARTIA™ Reconstructive Tissue Matrix
  • Ascent®
  • Atlas Wound Matrix
  • Avance® Nerve Graft
  • Avaulta Plus™
  • Avive®
  • AxoBioMembrane
  • Axograft™
  • AxoGuard® nerve connector
  • AxoGuard® nerve protector
  • Axolotl Ambient™
  • Axolotl Cryo™
  • Axolotl DualGraft™
  • Axolotl Graft™
  • Axolotl Shot™
  • BEAR® (Bridge-Enhanced ACL Repair) Implant
  • BellaCell HD
  • Belladerm®
  • BellaGen™
  • Bio-ConneKt®
  • BioDDryFlex® Resorbable Adhesion Barrier
  • Biodesign Nipple Reconstruction Cylinder
  • BioDExCel™
  • BioDFactor™
  • BioDFence™
  • BioDOptix™
  • Bioengineered autologous skin-derived products (for example, SkinTE™, MyOwn Skin™)
  • BioFiber™
  • BioFix
  • BioSkin® Flow Amniotic Wound Matrix
  • Biotape XM Tissue Matrix
  • BioVance®
  • BioWound
  • BioWound plus
  • BioWound Xplus
  • Cardiamend™
  • CardioCel®
  • CardioGRAFT®
  • Celera Dual Layer™
  • Celera Dual Membrane™
  • CellerateRX®
  • Cellesta amnion granulate
  • Cellesta amniotic membrane
  • Cellesta cord
  • Cellesta flowable amnion
  • Cellesta™ Amniotic Membrane
  • CG CryoDerm™
  • CLARIX™ 100 Quick-Peel Wound Matrix
  • CLARIX™ 1k
  • CLARIX™ FLO
  • Cocoon Membrane
  • Cogenex Amniotic Membrane
  • Cogenex Flowable Amnion
  • CollaFilm®
  • CollaFix™
  • CollaGUARD®
  • CollaMend™
  • COLLARX®
  • CollaSorb™
  • CollaWound™
  • Coll-e-Derm™
  • Collexa®
  • Collieva®
  • Conexa™
  • Connext™ Surgical Matrix
  • CoreCyte™
  • Coreleader Colla-Pad
  • Coretext™
  • CorMatrix®
  • Corova
  • Corplex™
  • Cortiva™ Allograft Dermis
  • C-QUR™
  • CRXa™
  • Cryo-Cord™
  • CryoMatrix®
  • CryoSkin®
  • Cuffpatch™
  • CYGNUS Matrix™
  • CYGNUS Max™
  • CYGNUS Solo™
  • Cymetra®
  • Cytal® Burn Matrix (formerly MatriStem)
  • Cytal® Multilayer Matrix (formerly MatriStem)
  • Cytal® Wound Matrix (formerly MatriStem)
  • Cytoflex®
  • Cytoplast™
  • DeNovo® NT Graft
  • Dermacyte
  • DermADAPT™ Wound Dressing
  • Derma-Gide®
  • DermaPure™
  • DermaSpan™
  • Dermavest 2™
  • Dermavest™
  • DermMatrix
  • Derm-Maxx
  • DressSkin™
  • DuraForm™
  • Duragen® XS
  • Duragen™ Plus
  • DuraMatrix™
  • Durepair® Regeneration Matrix
  • Endobon® Xenograft Granules
  • Endoform® Antimicrobial
  • Endoform® Natural Dermal Template
  • ENDURAgen™
  • Enverse®
  • EpiBurn
  • Epicel®
  • EpiDex®
  • EpiFix™, particulate or injectable form
  • EpiFlex®
  • Excellagen® 
  • Fibro-Gide®
  • FloGraft™
  • FlowerDerm™
  • FlowerFlo™ (FlowerAmnioFlo)
  • FlowerPatch™ (FlowerAMINOPatch)
  • Fluid flow™
  • Fluid GF™
  • FortaDerm™ Wound Dressing (see PuraPly™)
  • Fortiva™ Porcine Dermis
  • GalaFLEX®
  • GalaFORM®
  • GalaSHAPE® 3D
  • Gammagraft™
  • Genesis amniotic membrane
  • Gentrix® Surgical Matrix
  • GENTRIX™
  • GORE BIO-A® Fistula Plug
  • Gore® Acuseal Cardiovascular Patch
  • Grafix® CORE
  • GrafixPL PRIME®
  • Graftjacket™ Xpress injectable
  • GraftJacket™, injectable form
  • GraftRope™
  • HA Absorbent Wound Dressing
  • Helicoll
  • HeliMEND
  • Helisorb®
  • hMatrix®
  • Human health factor 10™ amniotic patch (hhf10-p)
  • Hyalomatrix®
  • Impax Dual Layer
  • Inforce®
  • InnovaMatrix® FS
  • Integra® Omnigraft Dermal Regeneration Template
  • Integra® Flow
  • InteguPly™
  • Interfy
  • Jaloskin®
  • Keramatrix®
  • Kerasorb®
  • KeraSys™
  • Keroxx Flowable Wound Matrix
  • LiquidGen™
  • Lyoplant® (See Tutopatch)
  • MatrACELL®
  • MatriDerm®
  • Matrion
  • MatriStem®
  • Matrix HD™
  • MatrixDerm™ (see Cytal)
  • Medeor™
  • MediHoney®
  • Mediskin®
  • Membrane Graft™
  • Membrane Patch™
  • Membrane Wrap ™
  • Memoderm™
  • Menaflex™ Collagen Meniscus Implant
  • Meso BioMatrix™
  • MIAMNION®
  • MIRODERM™
  • Microlyte matrix®
  • Miromatrix Biological Mesh
  • Miromesh®
  • MLG-Complete
  • MyOwn Skin
  • Myriad Matrix™
  • Myriad Morcells™
  • Nanofactor™ Flow
  • Nanofactor™ Membrane
  • Neoform Dermis™
  • Neopatch
  • NEOX® 100 Quick-Peel Wound Matrix
  • NEOX® 1k Wound Matrix
  • NEOX® FLO 
  • Neox RT®
  • Neuragen® Nerve Guide
  • Neuragen® Nerve Wrap
  • NeuraWrap™
  • Neuroflex™
  • NeuroMatrix™
  • NeuroMend™
  • NEVELIA® bi-layer matrix
  • Novachor
  • Novafix™
  • Novosorb™ Biodegradable Temporizing Matrix (BMT)
  • NuCel®
  • NuDyn™
  • NuShield®
  • Ologen™ Collagen Matrix
  • Omeza Collagen Matrix
  • Omnigraft (also see Integra Omnigraft Dermal Regeneration Template)
  • OrthADAPT™
  • Orthoflow
  • OsseoGuard®
  • Ovation®
  • PalinGen Flow™
  • PalinGen SportFlow™
  • PalinGen® Xplus Hydromembrane
  • PalinGen® Xplus Membrane
  • Pelvicol®
  • PelviSoft®
  • Pericol®
  • Peri-Guard® Repair Patch
  • Peri-Strips Dry®
  • Permacol™
  • PermeaDerm B
  • PermeaDerm C
  • PermeaDerm Glove
  • Phasix Mesh™
  • Phoenix™ Wound Matrix
  • PhotoFix® Decellularized Bovine Pericardium
  • Plurivest®
  • PolyCyte™
  • Preclude® Pericardial Membrane
  • Preclude® Vessel Guard
  • Procenta®
  • ProgenaMatrix™
  • ProLayer
  • ProMatrX ACF
  • Promogran™
  • Protext™
  • PTFE felt
  • Puracol®
  • PuraPly™ (see Fortaderm)
  • Puros® Dermis
  • PX50® and X50® Plus
  • ReCell® Autologous Harvesting Device
  • RegenePro™
  • REGENETEN™
  • REGUaRD
  • REVITA®
  • ReNu®
  • Renuva®
  • Repliform®
  • Repriza™
  • Restore® Orthobiologic Soft Tissue Implant
  • Restorigin
  • Restrata®
  • Revita®
  • Revitalon™
  • Rx Flow
  • Rx Membrane
  • Seamguard®
  • SERAGYN® BR
  • SERASYNTH® MESH
  • SERI® Surgical Scaffold
  • Signature A Patch
  • SIS Wound Dressing II
  • SJM™ Pericardial Patch
  • SkinTE
  • SportMatrix
  • SportMesh™
  • SS Matrix™
  • SteriGraft™
  • SteriMatrix™
  • SteriShield™
  • Stimulen™ Collagen
  • Stravix™
  • SUPRA SDRM®
  • Suprathel®
  • SureDerm®
  • SurFactor®
  • SurgiCord™
  • surgiGRAFT™
  • surgiGRAFT™ nano
  • surgiGRAFT™-Dual
  • SurgiMend®
  • Surgisis® (including Surgisis® AFP™ Anal Fistula Plug, Surgisis® Gold™ Hernia Repair Grafts, and Surgisis® Biodesign™)
  • SurGraft®
  • Symphony™
  • Talymed™
  • tarSys™
  • TenoGlide™
  • TenSIX™ 
  • TheraForm™ Standard/Sheet
  • TheraGenesis®
  • TiLOOP® Bra
  • TissueMend®
  • Tornier® BioFiber Absorbable Biological Scaffold
  • TranzGraft®
  • TruSkin™
  • Tutomesh™ Fenestrated Bovine Pericardium
  • Tutopatch™ Bovine Pericardium
  • Unite™
  • Vascu-Guard®
  • Veritas® Collagen Matrix
  • VersaShield™
  • VersaWrap®
  • VIA DERMIS™
  • Via Disc® NP
  • Viable Allograft Supplemental Disc Regeneration (VAST)
  • Viaflow
  • VIAGENEX®
  • Vendaje (Other than for ocular indications. See medically necessary section for use for ocular indications)
  • VIM® human amniotic membrane
  • WoundEx®
  • Woundfix Plus
  • Woundfix Xplus
  • Woundfix,
  • WoundFix™
  • Xceed™
  • Xcellistem®
  • XCM Biologic™
  • Xelma®
  • XenMatrix™ Surgical Graft
  • XenoSure® Biolog
  • X-Repair
  • Xwrap™ (Hydro, DRY, and ECM)
  • Zenith™ human amniotic membrane.