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Skin and Soft Tissue Substitutes – Commercial Medical Policy

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Skin and Soft Tissue Substitutes – Commercial Medical Policy UnitedHealthcare® Commercial Medical Policy Skin and Soft Tissue Substitutes Policy Number: 2021T0592I Effective Date: August 1, 2021 Instructions for Use Table of Contents Page Related Commercial Policies Coverage Rationale ....................................................................... 1 • Prolotherapy and Platelet Rich Plasma Therapies Documentation Requirements ...................................................... 3 • Breast Reconstruction Post Mastectomy and Poland Definitions ...................................................................................... 4 Syndrome Applicable Codes .......................................................................... 4 Description of Services ................................................................. 7 Community Plan Policy Clinical Evidence ........................................................................... 8 • Skin and Soft Tissue Substitutes U.S. Food and Drug Administration ........................................... 53 Medicare Advantage Coverage Summary References ................................................................................... 54 • Skin Treatment, Services and Procedures Policy History/Revision Information ........................................... 60 Instructions for Use ..................................................................... 60 Coverage Rationale EpiFix® Amnion/Chorion Membrane (Non-Injectable) EpiFix is proven and medically necessary for treating diabetic foot ulcer when all of the following criteria are met: • Adequate circulation to the affected extremity as indicated by one or more of the following: o Ankle-brachial index (ABI) between 0.7 and 1.2 o Dorsum transcutaneous oxygen test (TcPO2) ≥ 30 mm Hg o Triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg • Glycated hemoglobin test (HgA1c) < 12% (within the last 60 days) • Individual has a diagnosis of Type 1 or Type 2 diabetes • Serum creatinine < 3.0 mg/dL (within the last 6 months) • Ulcer size ≥ 1 cm2 and < 25 cm2 • Ulcer has failed to demonstrate Measurable Signs of Healing with at least 4 weeks of standard wound care which includes all of the following: o Application of dressings to maintain a moist wound environment o Debridement of necrotic tissue, if present o Offloading • EpiFix is used in conjunction with standard wound care • Individual does not have active Charcot deformity or major structural abnormalities of the foot • Individual does not have a diagnosis of autoimmune connective tissue disease • Individual does not have a known or suspected malignancy of current ulcer • Individual does not have an ulcer extending to tendon, muscle, capsule or bone • Individual is not receiving radiation therapy or chemotherapy • Individual is not taking medications considered to be immune system modulators EpiFix Application Limitations • EpiFix is limited to one application per week for up to 12 weeks Skin and Soft Tissue Substitutes Page 1 of 60 UnitedHealthcare Commercial Medical Policy Effective 08/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. Due to insufficient evidence of efficacy, EpiFix is unproven and not medically necessary for all other indications including but not limited to: • EpiFix application more frequently than once a week or beyond 12 weeks TransCyte™ TransCyte is proven and medically necessary for treating surgically excised Full-Thickness Thermal Burn wounds and deep Partial-Thickness Thermal Burn wounds before autograft placement. TransCyte is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy. Other Skin and Soft Tissue Substitutes The following skin and soft tissue substitutes are unproven and not medically necessary for any indication* due to insufficient evidence of efficacy: ® ® Affinity CLARIX FLO ™ AlloGen Cogenex (amniotic membrane and flowable amnion) ™ ™ AlloSkin Coll-e-Derm ® ™ AlloWrap Conexa ® ™ Altiply Corecyte ™ ™ ™ Amnio Wound Coretext or Protext ™ ® Amnio Wrap2 CorMatrix ™ ™ AmnioAMP-MP Corplex ™ AmnioArmor Corplex p ® ™ AmnioBand Cryo-Cord ™ AmnioCore Cygnus ™ ™ Amniocyte Plus Cymetra ® ™ ™ AMNIOEXCEL , AMNIOEXCEL Plus, or BioDExcel Cytal ® ® ® AmnioFix DermACELL *, DermACELL AWM or DermACELL ® ™ AMNIOMATRIX or BioDMatrix AWM Porous (see asterisked note below when ™ ™ Amnio-Maxx or Amnio-Maxx Lite DermACELL is used during breast reconstruction) ® Amniorepair Dermacyte ™ Amniotext Derma-Gide ™ Amniotext patch DermaPure ™ ™ Amnion Bio DermaSpan ™ ® ® AMNIPLY Dermavest or Plurivest ® Architect Derm-Maxx ® ® Artacent Cord EpiCord ® Artacent Wound or Artacent AC EpiFix , injectable ® ® ArthroFLEX Excellagen ™ ® Ascent E-Z Derm ™ ™ ™ AxoBioMembrane FlowerAmnioFlo or FlowerFlo ™ ™ Axolotl™ Ambient or Axolotl Cryo FlowerAmnioPatch or FlowerPatch ™ Axolotl Graft or Axolotl DualGraft FlowerDerm ™ ™ BellaCell HD Fluid Flow ® ™ bio-ConneKt Fluid GF ™ ™ ™ BioDfence or BioDFence DryFlex GammaGraft BionextPatch Genesis Amniotic Membrane ™ ® Bioskin Grafix ® Bioskin Flow GrafixPL ® ® Biovance Grafix PRIME ™ ® BioWound , BioWound Plus, or BioWound Xplus GrafixPL PRIME carePATCH Guardian ™ ™ Cellesta or Cellesta Duo Helicoll ® Cellesta Cord hMatrix ® Cellesta Flowable Amnion Hyalomatrix ® ® CLARIX Integra Flowable Wound Matrix Skin and Soft Tissue Substitutes Page 2 of 60 UnitedHealthcare Commercial Medical Policy Effective 08/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. InteguPly® ProMatrX™ Interfyl™ PuraPly®, PuraPly AM, or PuraPly XT Keramatrix® REGUaRD™ Kerasorb® Repriza® Kerecis™ Omega3 Restorigin™ Keroxx™ Revita™ Matrion™ Revitalon® MatriStem® SkinTE™ Mediskin™ STRATTICE™ Membrane Graft™ Stravix™ or StravixPL™ Membrane Wrap™ Surederm™ MemoDerm™ Surfactor® MIRODERM™ SurGraft™ MyOwn Skin™ SurgiCORD™ NeoPatch™ SurgiGRAFT™ NEOX® SurgiGRAFT-DUAL NEOX FLO® Talymed® Novachor™ TenSIX® Novafix™ TheraSkin® Novafix™ DL Therion™ NuDYN™ TranZgraft® NuShield® TruSkin™ PalinGen® Amniotic Tissue Allograft and PalinGen Flow WoundEx® products WoundEx™ Flow Polycyte™ WoundFix™, WoundFix Plus, or WoundFix Xplus PriMatrix® Xcellerate™ Procenta® XCM BIOLOGIC® Tissue Matrix ProgenaMatrix™ XWRAP™ *Refer to the Coverage Determination Guideline titled Breast Reconstruction Post Mastectomy for information about coverage for skin and soft tissue substitutes used during post mastectomy breast reconstruction procedures. Documentation Requirements Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested. HCPCS Codes* Required Clinical Information Transcyte Q4182 Medical notes documenting the following, when applicable: Documentation of a surgically excised full-thickness thermal burn wound(s) and deep partial- thickness thermal burn wound(s) before autograft placement (include the wound size, location, and measurements) Specific diagnostic image(s) that show the abnormality for which surgery is being requested; consultation with requesting surgeon may be of benefit to select the optimal images o Note: Diagnostic images must be labeled with: . The date taken . Applicable case number obtained at time of notification, or member's name and ID number on the image(s) o Submission of diagnostic imaging is required via the external portal at www.uhcprovider.com/paan; faxes will not be accepted Diagnostic image(s) report(s) Treatment plan, including frequency Skin and Soft Tissue Substitutes Page 3 of 60 UnitedHealthcare Commercial Medical Policy Effective 08/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. HCPCS Codes* Required Clinical Information EpiFix (for Treating Diabetic Foot Ulcer) Q4186 Medical notes documenting the following, when applicable: Diagnosis Relevant past medical history including Type 1 or Type 2 diabetes Wound type, size, location and stage Wound care history including but not limited to: o Prior treatments tried and failed or contraindicated. Include the dates and reason for discontinuation o Concurrent therapies, including prescribed medications Adequate circulation ABI, TcPO2 or arterial Doppler Relevant laboratory results (glycated hemoglobin test (HgA1c) and serum creatinine) Relevant diagnostic results (imaging studies) Treatment plan, including frequency *For code description, see the Applicable Codes section. Definitions Acellular Matrix: A Matrix that is derived from sources other than human skin. Acellular Matrices are the most frequently used skin substitute. Acellular Matrices are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017). Allogeneic Matrix: A Matrix that is derived from human tissue such as neonatal fibroblasts of the foreskin (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017). Composite Matrix: A Matrix that is derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen. These Matrices contain active cellular components that continue to generate compounds and protein that may accelerate wound healing (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017).
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