Breast reconstructive surgery using allogeneic acellular dermal matrix productsa (including each of the following: AlloDerm®, AlloMend®, Cortiva® [AlloMax™], DermACELL™, DermaMatrix™, FlexHD®, FlexHD® Pliable™, GraftJacket®; see Policy Guidelines) may be considered medically necessary:
when there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required,
when there is viable but compromised or thin postmastectomy skin flaps that are at risk of dehiscence or necrosis, or
the inframammary fold and lateral mammary folds have been undermined during mastectomy and reestablishment of these landmarks is needed.
Treatment of chronic, noninfected, full-thickness diabetic lower-extremity ulcers using the following tissue-engineered skin substitutes may be considered medically necessary:
AlloPatch®a
Apligraf®b
Dermagraft®b
Integra® Omnigraft™ Dermal Regeneration Matrix (also known as Omnigraft™) and Integra Flowable Wound Matrix.
Treatment of chronic, noninfected, partial- or full-thickness lower-extremity skin ulcers due to venous insufficiency, which have not adequately responded following a 1-month period of conventional ulcer therapy, using the following tissue-engineered skin substitutes may be considered medically necessary:
Apligraf®b
Oasis™ Wound Matrixc.
Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitutes may be considered medically necessary:
OrCel™ (for the 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 U.S. Food and Drug Administration [FDA])d.
Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:
Epicel® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area ≥30% when provided in accordance with the HDE specifications of the FDA)d
Integra® Dermal Regeneration Templateb.
a Banked human tissue.
b FDA premarket approval.
c FDA 510(k) clearance.
d FDA-approved under an HDE.
All other uses of the bioengineered skin and soft tissue substitutes listed above are considered investigational.
All other skin and soft tissue substitutes not listed above are considered investigational, including, but not limited to:
ACell® UBM Hydrated/Lyophilized Wound Dressing
AlloSkin™
AlloSkin™ RT
Aongen™ Collagen Matrix
Architect® ECM, PX, FX
ArthroFlex™ (Flex Graft)
AxoGuard®Nerve Protector (AxoGen)
Biobrane®/Biobrane-L
Bio-ConneKt® Wound Matrix
CollaCare®
CollaCare® Dental
Collagen Wound Dressing (Oasis Research)
CollaGUARD®
CollaMend™
CollaWound™
Coll-e-derm
Collexa®
Collieva®
Conexa™
Coreleader Colla-Pad
CorMatrix®
Cymetra™ (Micronized AlloDerm)™
Cytal™ (previously MatriStem®)
Dermadapt™ Wound Dressing
Derma-gide
DermaPure™
DermaSpan™
DressSkin
Durepair Regeneration Matrix®
Endoform Dermal Template™
ENDURAGen™
Excellagen®
ExpressGraft™
E-Z Derm™
FlowerDerm™
GammaGraft
Geistlich Derma-Gide™
GraftJacket® Xpress, injectable
Helicoll™
hMatrix®
Hyalomatrix®
Hyalomatrix® PA
InnovaMatrix
Integra™ Bilayer Wound Matrix
Integra® Matrix Wound Dressing (previously Avagen)
InteguPly®
Keramatrix®
Kerecis™ Omega3
Keroxx™
MatriDerm®
MatriStem
Matrix HD™
MicroMatrix®
Miroderm®
Mediskin®
MemoDerm™
Microderm® biologic wound matrix
MyOwn skin
Oasis® Burn Matrix
Oasis® Ultra
Ologen™ Collagen Matrix
Omega3 Wound (originally Merigen wound dressing)
Permacol™
PriMatrix™
PriMatrix™ Dermal Repair Scaffold
Progenamatrix
Puracol® and Puracol® Plus Collagen Wound Dressings
PuraPly™ Wound Matrix (previously FortaDerm™)
PuraPly™ AM (Antimicrobial Wound Matrix)
Puros® Dermis
RegenePro™
Repliform®
ReCell®
Repriza™
SkinTE™
StrataGraft®
Strattice™
Suprathel®
SurgiMend®
Talymed®
TenoGlide™
TenSIX™ Acellular Dermal Matrix
TissueMend
TheraForm™ Standard/Sheet
TheraSkin®
TransCyte™
TruSkin™
Veritas® Collagen Matrix
XCM Biologic® Tissue Matrix
XenMatrix™ AB.
