Wound Care Articles and Insights
September 5, 2023

CMS Update: Skin Substitutes and Tissue Based Product Guidelines

Vanessa Ploessel

This updated comprehensive free guide available below discusses upcoming changes in the use of skin substitute grafts and cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers. These changes will take effect on or after 10/1/2023, impacting several Medicare Administrative Contractors (MACs) including CGS, First Coast, and Novitas. Notable changes include new guidelines on skin substitute application frequency, the importance of vascular studies, requirements for addressing smoking cessation and glycemic control in documentation, guidelines to reduce excessive wastage, restrictions on same-day/site procedures, and a shift of certain products from covered to non-covered categories based on FDA approval and evidence-based literature. These changes aim to improve the effectiveness and efficiency of ulcer treatment. For a detailed explanation, download the PDF now. Check out the Updated Comprehensive Guide to see a map of which MACs will be impacted and find the updated list of included and excluded products.

UPDATE: The latest CMS regulation changes for Skin Substitute Grafts/cellular and/or Tissue-based products will NOT be effective on 10/1/23. The current LCD remains in effect as of 9/28/23. The current guide is still available as a reference for the planned regulation change. Stay tuned for more updates as we anticipate further changes.

Knowing of the impact that these changes can cause to centers, Wound Care Advantage has focused on preparing its network for success. Through a Program Director Fireside Chat, subject matter experts walked through the upcoming LCD changes, how the WCA Formulary can be utilized finding a covered CTP, and what product education opportunities are available to each center. Along with the Fireside Chat, additional outreach from the WCA Product Division has ensured that every center understands their options come October 1st. Wound Care Advantage will continue supporting each unique need and concern that arise with the pending changes. Learn more about how WCA assists wound programs with regulatory updates, documentation and compliance.

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