12/17/2025

Latest on Coverage of Skin Substitutes

Effective January 1, 2026

On December 15, 2025, CMS announced that all seven MACs will issue updated final “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers” LCDs, effective January 1, 2026.

These LCDs will govern coverage of skin substitute application to diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) for Medicare Part B beneficiaries. They will also continue to outline the applicable coverage criteria and documentation requirements for this service.

Under the updated LCDs:

• 18 products will be listed as “covered.”
• 158 products will be listed as “not covered.”
• A third list will include 154 additional products for which coverage will be determined at the discretion of the Part B MAC with jurisdiction where the service is performed.

For products in this third category to be covered, they must meet the “reasonable and necessary” standard under section 1862(a)(1)(A) of the Social Security Act, along with any other applicable requirements.

The full product lists and LCD details can be viewed here.