CMS Skin Substitutes
Where do providers stand on Skin Substitute Products?
CMS has delayed the final LCD coverage policies for skin substitute products for the treatment of diabetic foot ulcers and venous leg ulcers until January 1, 2026. The MACs initially proposed LCD L35041 to be released in April 2025 for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.
This delay means that Medicare will significantly limit the number of products that are approved for Skin Substitute Grafts/Cellular and Tissue-Based treatment of diabetic foot and venous leg ulcers. The LCD offers over 200 approved products. Medicare has approved only 18 products stating there is either no literature found or insufficient evidence for use of these skin substitutes on diabetic foot ulcers or venous leg ulcers.
Approved HCPCS codes:
Diabetic foot ulcers (DFU):
A2019, Q4101, Q4102, Q4105, Q4106, Q4107, Q4110, Q4121, Q4122, Q4128, Q4133, Q4151, Q4158, Q4159, Q4160, Q4186, Q4187, Q4203.
Venous leg ulcers (VLU)
Q4101, Q4102, Q4106, Q4151, Q4186.
What can you do?
Contact CMS at CAGInquiries@cms.hhs.gov by November 1, 2025, with skin substitute study results, peer-reviewed publications, and high-quality results from public sources. CMS will send the results and publications to your local MACs to review to determine if revisions to the LCD are appropriate.
Contact KZA at info@kzanow.com for support to meet medical necessity in the current policy.
Source:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35041