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| Medical Policy: | S-33-022 |
| Topic: | Bio-Engineered Skin and Soft Tissue Substitutes |
| Section: | Surgery |
| Effective Date: | January 1, 2017 |
| Issue Date: | January 2, 2017 |
| Last Reviewed: | April 2016 |
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 being evaluated for a variety of conditions, including breast reconstruction and to aid healing of lower extremity ulcers and severe burns. Acellular dermal matrix products are also being evaluated in the repair of a variety of soft tissues. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Breast reconstructive surgery using ONE of the following allogeneic acellular dermal matrix products may be considered medically necessary for ANY ONE of the following indications:
Product(s):
- AlloDerm®; or
- AlloMax™; 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 not be considered 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:
- Apligraf®; or
- Dermagraft®; or
- Integra® Dermal Regeneration Template; or
- Amniotic Membrane Graft (eg. Epifix®, Grafix®).
Services that do not meet the above criteria will not be considered 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-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 not be considered 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):
- 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 FDA
Services that do not meet the above criteria will not be considered medically necessary.
Treatment of second- and third-degree burns using ANY ONE of the following tissue-engineered skin substitutes may be considered medically necessary.
Services that do not meet the above criteria will not be considered 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 of greater than one month duration and which have not adequately responded following a one month period of conventional ulcer therapy (such as standard dressing changes, and standard therapeutic compression); or
- In conjunction with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than one month duration which have not adequately responded following at least a four week period of conventional ulcer therapy (such as surgical debridement, complete off-loading and standard dressing changes) and 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 (such as club release), radiation compromised wounds and necrotizing fasciitis.
Services that do not meet the above criteria will not be considered medically necessary.
ALL other skin and soft tissue substitutes not listed above are considered experimental/investigational, including, but not limited to:
- ACell® UBM Hydrated Wound Dressing
- ACell® UBM Lyophilized Wound Dressing
- ActiveMatrix®
- Affinity™
- AlloPatch HD™
- AlloSkin™
- AlloSkin™ RT
- Allowrap® DS
- Alphaplex with MariGen Omega3
- AmnioBand or Guardian
- Amniofix®
- Aongen™ Collagen Matrix
- AmnioMatrix™ (BioDMatrix)
- Architect Extracellular Matrix
- ArthroFlex™ (FlexGraft)
- Atlas Wound Matrix
- Artacent wound
- Avagen Wound Dressing
- Avaulta Plus™
- Biobrane®
- Biodexcel™ (AmnioExCel)
- BioDfence™
- BioDfence/BioDfactor
- BioDfence DryFlex™
- Biovance®
- CellerateRX®
- Collagen Sponge (Innocoll)
- Collagen Wound Dressing (Oasis Research)
- Collaguard
- CollaSorb™
- CollaWound™
- Collexa®
- Collieva®
- Conexa™
- Coreleader Colla-Pad
- CorMatrix®
- CRXa™
- Cymetra®
- Cytal
- DermACELL®
- Dermadapt™ Wound Dressing
- DermaMatrix Acellular Dermis
- DermaPure™
- Dermavest™
- DressSkin
- Durepair Regeneration Matrix®
- Endoform Dermal Template™
- ENDURAgen™
- Excellagen
- E-Z Derm™
- FortaDerm™ Wound Dressing
- GammaGraft
- GraftJacket® Regenerative Tissue Matrix
- GraftJacket® Xpress, injectable
- HA Absorbent Wound Dressing
- Helicoll
- Hyalomatrix® (Laserskin®)
- Hyalomatrix® PA
- hMatrix®
- Integra™ Flowable Wound Matrix
- Integra™ Bilayer Wound Matrix
- Integra™ Matrix
- Interfyl
- MatriDerm®
- MatriStem® Burn Matrix
- MatriStem® Micromatrix
- MatriStem® Wound Matrix
- Matrix HD™
- MediHoney®
- Mediskin®
- MemoDerm™
- Miroderm
- Neox®
- Neox100®
- Neox®Flo and Clarix®Flo
- Nushield™
- Oasis® Burn Matrix
- Oasis® Ultra Tri-Layer Matrix
- Palingen
- Permacol™
- PriMatrix
- Primatrix™ Dermal Repair Scaffold
- Puros® Dermis
- Puraply
- Repliform®
- Repriza™
- Revitalon™
- SS Matrix™
- Stimulen™ Collagen
- StrataGraft
- Strattice™ (xenograft)
- Suprathel®
- SurgiMend®
- Talymed®
- TenoGlide™
- Tensix™
- TheraForm™ Standard/Sheet
- Truskin
- Unite® Biomatrix
- Veritas® Collagen Matrix
- Xcm Biologic Tissue Matrix
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
The Application of Bio-Engineered Skin and Soft Tissue Substitutes is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Outpatient HCPCS (C Codes) |
| C5271 | C5272 | C5273 | C5274 | C5275 |
| C5276 | C5277 | C5278 | C9349 | C9354 |
| C9356 | C9358 | C9360 | C9363 | C9364 |
| Links |
- Link to Provider Resource Center for the Medical Policy Update
04/2016, Products Approved for Treatment of Diabetic Lower Extremity Ulcers
05/2016, Integra Matrix and DermACELL Considered/Experimental/Investigational
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
