By the WoundSource Editors
Mississauga, ON – March 7, 2017 – NOVADAQ recently announced that Cigna has reviewed the growing base of evidentiary support and now covers DermACELL when used in association with a covered medically necessary breast reconstruction procedure. DermACELL AWM® has also been approved for coverage as medically necessary for diabetic foot ulcers when the following criteria are met: partial- or full-thickness diabetic foot ulcers of greater than four weeks duration for which standard wound therapy has failed; the treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of ≥ 0.70. Now more than 15 million Cigna members throughout 30 states including Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Maryland, Missouri, North and South Carolina, Tennessee, Texas and Virginia will have coverage for DermACELL and DermACELL AWM. Cigna joins several other payers who cover DermACELL including Medicare and UnitedHealthCare.
DermACELL is decellularized using Matracell®, a proprietary technology that removes more than 97 percent of donor DNA without compromising the desired biomechanical or biochemical properties.1 It also allows for rapid cellular infiltration and re-vascularization.2 LifeNet Health's Preservon® technology allows the tissue to be stored fully hydrated at ambient temperature, eliminating the need for refrigeration and re-hydration processes. DermACELL is also rendered terminally sterile to medical device-grade standards and has a sterility assurance level of 10-6.1.
NOVADAQ’s global mission is to enable physicians with point-of-care imaging solutions that provide real time clinically significant and actionable information to improve care quality and lower healthcare costs.
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About LifeNet Health
LifeNet Health is a non-profit global leader in regenerative medicine and the world's largest provider of allograft bio-implants and organs for transplantation.
Majority of commercial payers have skin substitute policies that state acellular dermal matrices are considered medically necessary when medical requirements for utilization are met and list several ADMs as examples. These medical policies are not mandating that only the listed examples are covered.
IMPORTANT! Federal Employee Programs (FEP) and other employer groups may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
1. Vashi, Christopher. "Clinical Outcomes for Breast Cancer Patients Undergoing Mastectomy and Reconstruction with Use of DermACELL, a Sterile, Room Temperature Acellular Dermal Matrix." Clinical Outcomes for Breast Cancer Patients Undergoing Mastectomy and Reconstruction with Use of DermACELL, a Sterile, Room Temperature Acellular Dermal Matrix (2014): n. pag. Web. 3 Mar. 2017.
2. Capito, A.E. et al. “Evaluation of Host Tissue Integration, Revascularization, and Cellular Infiltration Within Various Dermal Substrates". Annals of Plastic Surgery (May 2012)
MS-0849 Rev A NOVADAQ is a registered trademark of NOVADAQ Technologies, Inc. DERMACELL, DERMACELL AWM, PRESERVON and MATRACELL are registered trademarks of LifeNet Health, Inc.