(April 11, 2025) The  “future effective date” of the local coverage determinations for use of CTPs (skin substitutes) in diabetic foot ulcer and venous leg ulcer have been delayed until January 1, 2026. Today's announcement from CMS states: "As part of the transition to a new Administration, CMS is reviewing its coverage policies for skin substitute products. CMS believes it is important to maintain patient access to skin substitute products with high quality evidence of effectiveness. Because of this review, the Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Final Local Coverage Determinations effective date will be delayed until January 1, 2026. The Agency requests that any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted to CMS at This email address is being protected from spambots. You need JavaScript enabled to view it. by November 1, 2025. CMS will ensure all evidence received will be sent to the MACs to review to determine if revisions to the LCD are appropriate." 

Originally finalized in November 2024 with a February 2026 implementation date, the LCDs were delayed until April by President Trump's January executive orders directing a 60-day review period and a regulatory freeze on broad categories of government policies, then delayed again until January 2026 with the opportunity for manufacturers to submit new evidence. 

See CMS Announcement
See LCDs
See Alliance Statement on Final LCDs
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