Issue Description
This Local Coverage Determination (LCD) has been developed to create a policy consistent with current evidence. This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) in the Medicare population. DFUs and VLUs have multifactor etiologies requiring targeted therapy. Both are associated with significant morbidity, including amputations, and diminished quality of life. Numerous remedies including systemic and local treatments have been proposed. Skin substitute grafts/CTP are marketed as purported treatments for these ulcers. Their effectiveness is currently an active area of investigation. Despite lack of definitive improved health outcomes in the Medicare population, coverage will be provided for skin substitute grafts/CTP that have peer-reviewed, published evidence supporting their use as an adjunctive treatment for chronic ulcers shown to have failed established methods of healing.
