CMS Updates Medicare Coverage for Skin Substitute Products in 2026

The Centers for Medicare & Medicaid Services (CMS) announced that all seven Medicare Administrative Contractors (MACs) will update their Final Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products used in treating diabetic foot ulcers and venous leg ulcers effective January 1, 2026. These updated LCDs will govern access and payment for these products under Medicare for these specific indications, while maintaining frequency and utilization limits to ensure patient safety and appropriate use. The LCD updates follow an extended review period initiated under the previous administration, allowing manufacturers to submit evidence supporting the effectiveness of their products. CMS received evidence submissions for 66 skin substitute products by the November 1, 2025 deadline, categorizing them into covered, discretionary, and non-covered groups based on clinical evidence quality. Products classified under the 12-month status quo category will not have definitive coverage policies yet but must still meet the Social Security Act's reasonable and necessary criteria to be reimbursed; during this period, MACs can exercise discretion on payment as further studies are conducted. A reconsideration of the LCDs is scheduled for early 2027, providing an opportunity to reassess coverage based on new evidence. This process aims to balance evidence-based policy with market stability and manufacturer compliance with clinical standards. The MACs have currently identified 18 covered products, including Grafix Prime, which met evidence thresholds through a randomized controlled trial published in April 2025. CMS's approach seeks to reduce Medicare spending waste in this sector while maintaining access to effective therapies for Medicare beneficiaries.