This policy version was replaced January 1, 2024. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
Bioengineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), nonhuman tissue (xenographic), synthetic materials, or a composite of these materials. Bioengineered skin and soft tissue substitutes are being evaluated for a variety of conditions including breast reconstruction, tendon repair, healing lower-extremity ulcers and treatment of severe burns.
Regulatory status of bioengineered skin and soft tissue substitutes by the U.S. Food and Drug Administration (FDA) varies depending on the materials used and intended function of the tissue. Acellular dermal matrix (ADM) products derived from donated human skin tissue are supplied by tissue banks compliant with standards of the American Association of Tissue Banks (AATB) and FDA guidelines. The processing removes the cellular components (i.e., epidermis, all viable dermal cells) that can lead to rejection and infection. ADM products from human skin tissue are regarded as minimally processed and not significantly changed in structure from the natural material; FDA classifies ADM products as banked human tissue and therefore, not requiring FDA approval. Products in this category include but are not limited to AlloDerm®, Cortiva® (formerly AlloMax™), AlloMend®, AlloPatch®, DermACELL™, DermaPure™, and Graftjacket® Regenerative Tissue Matrix.
Products that utilize xenogenic materials, such as porcine tissue, to provide scaffolding for healing are subject to the 510(k) marketing clearance process. These include but are not limited to Cytal™, Biodesign Anal Fistula Plug, Oasis™ Wound Matrix, Permacol™, PriMatrix™, SIS Fistula Plug, Suprathel®, SurgiMend®, and Surgisis® rectal and vaginal fistula plugs.
Interactive wound and burn dressings, including those with living cells and biosynthetic products, are approved under the FDA PMA process as class III devices. These include but are not limited to Apligraf®, Dermagraft®, Epicel®, OrCel™ and TheraSkin®.
Two bioengineered skin substitutes have received FDA approval under a humanitarian device exemption (HDE), which is reserved for those medical devices (known as humanitarian use devices) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. An HDE is exempt from the effectiveness requirements of other FDA approval processes and is subject to certain profit and use restrictions. These include Epicel®, which has received an HDE approval from the FDA for the treatment of deep dermal or full-thickness burns comprising a total body surface area of 30% or more, and OrCel™, which received an HDE approval for use in patients with recessive dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites.
I. Breast reconstructive surgery following mastectomy using allogeneic acellular dermal matrix products, including but not limited to the following, is considered MEDICALLY NECESSARY AND APPROPRIATE:
II. Treatment of chronic, noninfected, full-thickness diabetic lower-extremity ulcers using the following tissue engineered skin substitutes may be considered MEDICALLY NECESSARY AND APPROPRIATE:
III. 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 AND APPROPRIATE:
IV. Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered MEDICALLY NECESSARY AND APPROPRIATE:
V. Treatment of dystrophic epidermolysis bullosa using OrCel™ for mitten-hand deformity when standard wound therapy has failed may be considered MEDICALLY NECESSARY AND APPROPRIATE.
VI. All other uses of the bioengineered skin and soft tissue substitutes listed above are considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
VII. All other skin and soft tissue substitutes not listed above are considered EXPERIMENTAL/INVESTIGATIVE for all indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes including, but not limited to:
A2001 A2002 A2004 A2005 A2006 A2007 A2008 A2009 A2010 A2011 A2012 A2013 A2014 A2015 A2016 A2017 A2018 A4100 15150 15151 15152 15155 15156 15157 15271 15272 15273 15274 15275 15276 15277 15278 15777 C1763 C1832 C5271 C5272 C5273 C5274 C5275 C5276 C5277 C5278 C9354 C9356 C9358 C9360 C9363 C9364 Q4100 Q4101 Q4102 Q4103 Q4104 Q4105 Q4106 Q4107 Q4110 Q4111 Q4112 Q4113 Q4114 Q4115 Q4116 Q4117 Q4118 Q4121 Q4122 Q4123 Q4124 Q4125 Q4126 Q4127 Q4128 Q4130 Q4134 Q4135 Q4136 Q4141 Q4142 Q4143 Q4146 Q4147 Q4149 Q4152 Q4158 Q4164 Q4165 Q4166 Q4167 Q4179 Q4182 Q4195 Q4196 Q4197 Q4200 Q4202 Q4203 Q4220 Q4222 Q4226 Q4238
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
