| Highmark Commercial Medical Policy - Pennsylvania |
| 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):
Indication(s):
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:
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:
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):
Indication(s):
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:
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:
| 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 |
04/2016, Products Approved for Treatment of Diabetic Lower Extremity Ulcers
05/2016, Integra Matrix and DermACELL Considered/Experimental/Investigational
