HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-33-046
Topic:
Bioengineered Skin
Section:
Surgery
Effective Date:
October 1, 2024
Issued Date:
October 1, 2024
Last Revision Date:
September 2024
Annual Review:
June 2024
 
 

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 utilized in the treatment for breast reconstruction, healing of lower extremity ulcers and severe burns. Acellular dermal matrix (ADM) products are utilized in the repair of a variety of soft tissues.

Policy Position

Breast reconstructive surgery using ONE of the following allogeneic ADM products may be considered medically necessary for any ONE of the following indications:

Product(s):

  • AlloDerm®; or
  • AlloMax™; or
  • AlloMend®; or
  • DermaMatrix™; or
  • DermACELL®; 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.

Breast reconstruction surgery using one of the allogeneic ADM products not meeting the criteria as indicated in this policy is considered not medically necessary.

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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:

  • AlloPatch®; or
  • Apligraf®; or
  • Dermagraft®; or
  • Integra® Dermal Regeneration Template or
  • Oasis® Ultra Tri-Layer Matrix or
  • Oasis Wound Matrix.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers not meeting the criteria as indicated in this policy will be considered not medically necessary.

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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 (1) 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; or
  • Oasis® Ultra Tri-Layer Matrix.

Treatment of chronic, non-infected, partial- or full-thickness lower extremity skin ulcers due to venous insufficiency not meeting the criteria as indicated in this policy is considered not medically necessary.

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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): 

  • 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 Food and Drug Administration (FDA). 

Treatment of dystrophic epidermolysis bullosa not meeting the criteria as indicated in this policy is considered not medically necessary.

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Treatment of second- and third-degree burns using any ONE of the following tissue-engineered skin substitutes may be considered medically necessary.

  • Epicel®
    • Treatment of deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30% when provided in accordance with the HDE specifications of the FDA; or
  • Integra Dermal Regeneration Template™; or
  • TransCyte™. 

Treatment of second- and third-degree burns not meeting the criteria as indicated in this policy is considered not medically necessary.

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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 greater than one (1) month duration and which have not adequately responded following a one (1) month period of conventional ulcer therapy (e. g., standard dressing changes, standard therapeutic compression, etc.); or
  • In conjunction with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers greater than one (1)-month duration which have not adequately responded following at least four (4) weeks of conventional ulcer therapy (e. g., surgical debridement, complete off-loading and standard dressing changes, etc.) 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 (e. g., club release, etc.), radiation compromised wounds and necrotizing fasciitis.

TheraSkin® not meeting the criteria as indicated in this policy is considered not medically necessary.

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ALL other skin and soft tissue substitutes not listed above are considered experimental/investigational and, therefore, non-covered, because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature. 

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Related Policies

Refer to Medical Policy S-249, Amniotic Membrane and Amniotic Fluid for additional information.


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



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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.

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.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

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.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    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.