CMS Withdraws Local Coverage Determinations for Certain Skin Substitutes

On Wednesday, December 24, the Centers for Medicare and Medicaid Services (CMS) announced the withdrawal of the final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs). The LCDs, if implemented, would have dramatically limited the number of skin substitute products covered and paid for under the Medicare program for DFUs and VLUs starting January 1, 2026.  
 
AATB remains concerned, however, that CMS has not indicated any intent to increase the scheduled payment rate for skin substitutes of $127.14/cm2. Without further action from CMS, this rate will take effect on January 1, 2026, for skin substitutes furnished in office and outpatient settings, as CMS finalized under the calendar year (CY) 2026 Medicare Physician Fee Schedule and Medicare Hospital Outpatient Prospective Payment System final rules. In a letter to CMS on December 4, 2025, AATB expressed concerns about the impact of the LCDs on patient access; we continue to strongly advise the agency to revise and increase the final payment rate to a more sustainable level for CY 2026. AATB believes that a fair reimbursement process that takes into consideration the cost of manufacturing human tissue products is essential to preserve patient access to these life-changing treatments.