Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), non-human tissue (xenographic), synthetic materials, or a composite of these materials. Bio-engineered skin and soft tissue substitutes are utilized in the treatment for breast reconstruction, healing of lower extremity ulcers and severe burns. Acellular dermal matrix (ADM) products are utilized in the repair of a variety of soft tissues.

Breast reconstructive surgery using ONE of the following allogeneic ADM products may be considered medically necessary for ANY ONE of the following indications:

Product(s):

• AlloDerm®; or
• AlloMax™; or
• AlloMend®; or
• DermaMatrix™; or
• FlexHD®; or
• GraftJacket®.

Indication(s):

• When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required; or
• When there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis; or
• The infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed.

Services that do not meet the above criteria will be considered not medically necessary.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers using ANY ONE of the following tissue-engineered skin substitutes may be considered medically necessary:

• AlloPatch®; or
• Apligraf®; or
• Dermagraft®; or
• Integra® Dermal Regeneration Template.

Services that do not meet the above criteria will be considered not medically necessary.

Treatment of chronic, non-infected, partial- or full-thickness lower extremity skin ulcers due to venous insufficiency, which have not adequately responded following a one (1)-month period of conventional ulcer therapy, using ANY ONE of the following tissue-engineered skin substitutes may be considered medically necessary:

• Apligraf; or
• Oasis™ Wound Matrix.

Services that do not meet the above criteria will be considered not medically necessary.

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitutes may be considered medically necessary for ALL of the following indications:

Product(s):

• OrCel™.

Indication(s): 

• Treatment of mitten-hand deformity when standard wound therapy has failed; and
• When provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the Food and Drug Administration (FDA). 

Services that do not meet the above criteria will be considered not medically necessary.

Treatment of second- and third-degree burns using ANY ONE of the following tissue-engineered skin substitutes may be considered medically necessary.

• Epicel®
  • Treatment of deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30% when provided in accordance with the HDE specifications of the FDA; or
• Integra Dermal Regeneration Template™; or
• TransCyte™. 

Services that do not meet the above criteria will be considered not medically necessary. 

TheraSkin® may be considered medically necessary for ANY ONE of the following indications:

• In conjunction with standard therapeutic compression for the treatment of chronic, non-infected, partial or full-thickness skin ulcers due to venous insufficiency greater than one (1)-month duration and which have not adequately responded following a one (1)-month period of conventional ulcer therapy (i.e., standard dressing changes, standard therapeutic compression, etc.); or
• In conjunction with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers greater than one (1)-month duration which have not adequately responded following at least four (4) weeks of conventional ulcer therapy (i.e., surgical debridement, complete off-loading and standard dressing changes, etc.) which can extend through the dermis, including tendon, muscle, joint capsule or bone exposure; or
• Other uses supported by clinical results and clinical literature include pressure sores, skin cancer excision (e.g., Mohs Surgery), large surgical wounds (i.e., club release, etc.), radiation compromised wounds and necrotizing fasciitis.

Services that do not meet the above criteria will be considered not medically necessary.

ALL other skin and soft tissue substitutes not listed above are considered experimental/investigational and, therefore, non-covered, because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature. This includes, but is not limited to:

• ACell® UBM Hydrated Wound Dressing; and 
• ACell® UBM Lyophilized Wound Dressing; and
• ActiveMatrix®; and
• Affinity™; and
• AlloSkin™; and
• AlloSkin™ RT; and
• Allowrap® DS; and
• Alphaplex with MariGen Omega3; and
• Amniofix®; and
• Aongen™ Collagen Matrix; and
• AmnioMatrix™ (BioDMatrix); and
• Amnio Wound; and
• Architect Extracellular Matrix; and
• ArthroFlex™ (FlexGraft); and
• Atlas Wound Matrix; and
• Artacent wound; and
• Avagen Wound Dressing; and
• Avaulta Plus™; and
• Biobrane®; and
• Biodexcel™ (AmnioExCel); and
• BioDfence™; and
• BioDfence/BioDfactor; and
• BioDfence DryFlex™; and
• CellerateRX®; and
• Collagen Sponge (Innocoll); and
• Collagen Wound Dressing (Oasis Research); and
• Collaguard; and
• CollaSorb™; and
• CollaWound™; and
• Collexa®; and
• Collieva®; and
• Conexa™; and
• Coreleader Colla-Pad; and
• CorMatrix®; and
• CRXa™; and
• Cymetra®; and
• Cytal; and
• DermACELL®; and 
• Dermadapt™ Wound Dressing; and
• DermaMatrix Acellular Dermis; and
• DermaPure™; and
• Dermavest™; and
• DressSkin; and
• Durepair Regeneration Matrix®; and
• Endoform Dermal Template™; and
• ENDURAgen™; and
• Excellagen; and
• E-Z Derm™; and
• FlowerDerm; and
• FlowerPatch™; and
• FortaDerm™ Wound Dressing; and
• GammaGraft; and
• GraftJacket® Regenerative Tissue Matrix; and
• GraftJacket® Xpress, injectable; and
• HA Absorbent Wound Dressing; and
• Helicoll; and
• Hyalomatrix® (Laserskin®); and
• Hyalomatrix® PA; and
• hMatrix®; and
• Integra™ Flowable Wound Matrix; and
• Integra™ Bilayer Wound Matrix; and
• Integra™ Matrix; and
• Interfyl; and
• MatriDerm®; and
• MatriStem® Burn Matrix; and
• MatriStem® Micromatrix; and
• MatriStem® Wound Matrix; and
• Matrix HD™; and
• MediHoney®; and
• Mediskin®; and
• MemoDerm™; and
• Miroderm; and
• Neox®; and
• Neox100®; and
• Neox®Flo and Clarix®Flo; and
• NeoPatch; and
• Nushield™; and
• Oasis® Burn Matrix; and
• Oasis® Ultra Tri-Layer Matrix; and
• Palingen; and
• Permacol™; and
• PriMatrix; and
• Primatrix™ Dermal Repair Scaffold; and
• Puros® Dermis; and
• Puraply; and
• Repliform®; and
• Repriza™; and
• Revita; and
• Revitalon™; and
• SS Matrix™; and
• Stimulen™ Collagen; and
• StrataGraft; and
• Strattice™ (xenograft); and
• Suprathel®; and
• SurgiMend®; and
• Talymed®; and
• TenoGlide™; and
• Tensix™; and
• TheraForm™ Standard/Sheet; and
• Truskin; and
• Unite® Biomatrix; and
• Veritas® Collagen Matrix; and
• Xcm Biologic Tissue Matrix.