CMS reviewing coverage policies for skin substitute products

CMS issued the following statement on Local Coverage Determination for certain skin substitute grafts: “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… 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.” Companies that may be impacted include MiMedx (MDXG) and Organogenesis (ORGO).