Update-CMS Delay of Skin Substitutes Effective Date

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 1/1/2026. 

CMS requests that any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted to CMS at CAGInquiries@cms.hhs.gov by 11/1/2025. 

For more information on the LCD process, see https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/coverage/local-coverage-determination-process-and-timeline.

Link to Press release is here: 
CMS Statement on Local Coverage Determination for Certain Skin Substitute Grafts

Posted 4/18/2025