Tissue-Engineered Skin Substitutes

1 Page 1 of 159 Medical Coverage Policy: 0068 Medical Coverage Policy Effective Date .. 11/15/2022 Next Review Date .. 3/15/2023 Coverage Policy Number .. 0068 Tissue-Engineered Skin Substitutes Table of Contents Overview .. 1 Coverage Policy .. 1 General Background .. 24 Medicare Coverage Determinations .. 109 Coding Information .. 110 References .. 117 Related Coverage Resources Autologous Platelet Derived Growth Factors (Platelet-Rich Plasma [PRP]) Bone, Cartilage, Ligament Graft Substitutes Breast Reconstruction Following Mastectomy or Lumpectomy Electrical Stimulation Therapy and Devices in a Home Setting Hyperbaric & Topical Oxygen Therapies Injectable Fillers Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions, Including Sacroiliac Fusion Negative Pressure Wound Therapy/Vacuum-Assisted Closure (VAC)

2 For Nonhealing Wounds Plantar Fasciitis Treatments Scar Revision INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based.

3 For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.

4 Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This Coverage Policy addresses tissue engineered skin Substitutes and the various proposed indications for their use in multiple conditions.

5 Coverage Policy Each of the following skin grafts is considered medically necessary for wound closure: autologous skin graft (CPT Codes 15040-15261) Page 2 of 159 Medical Coverage Policy: 0068 unprocessed allogeneic human, cadaver skin graft (CPT Codes 15271-15278; HCPCS Code Q4100) unprocessed allogeneic pig skin graft (CPT Codes 15271-15278; HCPCS Code Q4100) Each of the following products is considered medically necessary as indicated: Skin Substitute Indication Criteria Application CPT /HCPCS Codes Product HCPCS Codes AlloDerm Breast reconstruction Considered medically necessary when used in association with a covered, medically necessary breast reconstruction procedure 15777 Q4116 AlloMax Breast reconstruction Considered medically necessary when used in association with a covered, medically necessary breast reconstruction procedure 15777 Q4100 C1781 AlloPatch Pliable Diabetic foot ulcer Considered medically necessary when ALL of the following criteria are met.

6 Full-thickness diabetic foot ulcer of greater than six weeks duration for which standard therapy has failed type I or type II diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of When the above medical necessity criteria are met, the following conditions of coverage apply: treatment is limited to one initial application additional applications for up to a maximum of eight in 12 weeks when there is evidence of wound healing ( , signs of epithelialization and reduction in ulcer size) Additional applications beyond 12 weeks are considered not medically necessary regardless of wound status 15275-15278 Q4128 AmnioBand Diabetic foot ulcer Considered medically necessary when ALL of the following criteria are met.

7 Full-thickness diabetic foot ulcer of greater than six weeks duration for which standard therapy has failed type I or type II diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of When the above medical necessity criteria are met, the following conditions of coverage apply: 15275-15278 Q4151 Q4168 Page 3 of 159 Medical Coverage Policy: 0068 Skin Substitute Indication Criteria Application CPT /HCPCS Codes Product HCPCS Codes treatment is limited to one initial application additional applications for up to a maximum of eight in 12 weeks when there is evidence of wound healing ( , signs of epithelialization and reduction in ulcer size) Additional applications beyond 12 weeks are considered not medically necessary regardless of wound status.

8 Apligraf Diabetic foot ulcer Considered medically necessary when ALL of the following criteria are met: full-thickness diabetic foot ulcer of greater than three weeks duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of When the above medical necessity criteria are met, the following conditions of coverage apply: treatment is limited to one initial application additional applications at a minimum of one week intervals, for up to a maximum of four in 12 weeks are considered medically necessary when evidence of wound healing is present ( , signs of epithelialization and reduction in ulcer size) Additional applications beyond 12 weeks are considered not medically necessary regardless of wound status.

9 15275-15278 Q4101 Apligraf venous stasis ulcer Considered medically necessary when BOTH of the following criteria are met: partial- or full-thickness venous stasis ulcer of greater than four weeks duration for which standard wound therapy has failed treated lower extremity has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of 15271-15278 Q4101 Page 4 of 159 Medical Coverage Policy: 0068 Skin Substitute Indication Criteria Application CPT /HCPCS Codes Product HCPCS Codes When the above medical necessity criteria are met, the following conditions of coverage apply: treatment is limited to one initial application additional applications at a minimum of one week intervals, for up to a maximum of four in 12 weeks when evidence of wound healing is present ( , signs of epithelialization and reduction in ulcer size) Additional applications beyond 12 weeks are considered not medically necessary regardless of wound status.

10 Biobrane Burn wound Considered medically necessary when used for temporary covering of a partial-thickness freshly debrided or excised burn wound 15271-15278 C5271-C5278 Q4100 C9399 Biobrane-L Burn wound Considered medically necessary when BOTH of the following criteria are met: temporary covering of a partial-thickness freshly debrided or excised burn wound adjunct to meshed autograft 15271-15278 C5271-C5278 Q4100 C9399 Cortiva Breast reconstruction Considered medically necessary when used in association with a covered, medically necessary breast reconstruction procedure 15777 Q4100 C9399 DermACELL Breast reconstruction Considered medically necessary when used in association with a covered, medically necessary breast reconstruction procedure 15777 Q4122 DermACELL AWM Diabetic foot ulcer Considered medically necessary when ALL of the following criteria are met.