Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)

All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.Pourmoussa A, Gardner DJ, Johnson MB, Wong AK. An update and review of cell-based wound dressings and their integration into clinical practice.Ann Transl Med. 2016 Dec;4(23):457. doi:10.21037/atm.2016.12.44.Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD:Agency for Healthcare Research and Quality. February 2020. http://www.ahrq.gov/research/findings/ta/index.html. Accessed April 27, 2021.Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds.Adv Wound Care. 2015 Sep 1;4(9):560-582. doi:10.1089/wound.2015.0635.U.S. Food and Drug Administration. Premarket Notification 510(k).Division of Industry and Consumer Education.March 2020. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Accessed December 9, 2021.U.S. Food and Drug Administration. FDA announces comprehensive regenerative medicine policy framework.FDA News Release. 2017 Nov 15. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework. Accessed April 27, 2021.U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use-Guidance for Industry and Food and Drug Administration Staff.Center for Biologics Evaluation and Research.Center for Devices and Radiological Health. Office of Combination Products. July 2020. https://www.fda.gov/media/109176/download. Accessed December 9, 2021.Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi:10.1016/j.jvs.2015.10.003.Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines.Wound Repair Regen. 2016 Jan-Feb;24(1):112-26. doi:10.1111/wrr.12391.Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers.Wound Repair Regen. 2016 Jan-Feb;24(1):136-44. doi:10.1111/wrr.12394.O'Donnell TF Jr, Passman MA, Marston WA, et al; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi:10.1016/j.jvs.2014.04.049.Rayman G, Vas P, Dhatariya K, et al. International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi:10.1002/dmrr.3283.Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update).Diabetes Metab Res Rev.2020 Mar;36 Suppl 1:e3266. doi:10.1002/dmrr.3266.Agency for Healthcare Research and Quality (AHRQ). Evidence-based Practice Center Technical Brief Protocol. Project Title: Skin Substitutes for Treating Chronic Wounds. 2018 (rev 2019). https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-substitute_0.pdf. Accessed April 20, 2021.Nathoo R, Howe N, Cohen G. Skin substitutes: an overview of the key players in wound management.J Clin Aesthet Dermatol. 2014;7(10):44-48.U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. July 2021. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies. Accessed February 16, 2022.Santema TB, Poyck PPC, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes.Cochrane Database of Systematic Reviews. 2016, Issue 2. Art. No.: CD011255. doi:10.1002/14651858.CD011255.pub2.Jones JE, Nelson EA, Al-Hity A. Skin grafting for venous leg ulcers.Cochrane Database of Systematic Reviews2013, Issue 1. Art. No.: CD001737. doi:10.1002/14651858.CD001737.pub4.Barbul A, Gurtner GC, Gordon H, Bakewell K, Carter MJ. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.Wound Repair Regen. 2020 Jan;28(1):81-89. doi:10.1111/wrr.12767.Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.Wound Repair Regen. 2017 May;25(3):483-497. doi:10.1111/wrr.12551.Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment.Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi:10.1111/wrr.12357.Lavery LA, Fulmer J, Shebetka KA, et al; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J.2014 Oct;11(5):554-60. doi:10.1111/iwj.12329.Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft.Ostomy Wound Manage. 2014 Sep;60(9):26-38.Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.Int Wound J. 2017 Apr;14(2):307-315. doi:10.1111/iwj.12600.Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.Wounds. 2019 Mar;31(3):68-74.Harding K, Sumner M, Cardinal M. A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.Int Wound J. 2013 Apr;10(2):132-7. doi:10.1111/iwj.12053.Snyder DL, Sullivan N, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Report Project ID No. HCPR0610. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. HHSA 290-2007-10063) Rockville, MD:Agency for Healthcare Research and Quality. December 2012. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. Accessed June 11, 2021.