Press Releases Apr 25, 2024

CMS Statement on Proposed Local Coverage Determination (LCD) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

CMS is aware that on April 25, 2024, the Medicare Administrative Contractors (MACs) released a proposed Local Coverage Determination (LCD) to provide appropriate coverage for skin substitute grafts used for chronic non-healing diabetic foot and venous leg ulcers. The MACs issued the collaborative proposed Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs) LCD to make sure that Medicare covers, and people with Medicare have access to, skin substitute products that are supported by evidence that shows that they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population and that coverage aligns with professional guidelines for appropriately managing these wounds.  

CMS strongly encourages interested parties to take advantage of the opportunity under the LCD process to provide comments to the MACs during the public comment period, which is open until June 8, 2024.  As part of the LCD process, each of the MACs will be holding public listening sessions in May to provide additional engagement opportunities on this proposed coverage policy. 

Ensuring people with Medicare have access to clinically appropriate items and services is a priority for CMS. CMS will closely monitor this LCD process to ensure that there are adequate and meaningful opportunities for engagement. 

Additional Information

The LCD process allows for all interested parties to submit comments on the proposed LCD.  The comment period is open until June 8, 2024.  Please visit your MAC’s website to click on a link to submit comments on the proposed LCD. Additionally, the LCD process allows for all interested parties within a MAC’s jurisdiction to attend an Open Meeting where the proposed LCD will be discussed.  Please visit your MAC’s website or the CMS Landing Page at https://www.cms.gov/medicare/coverage/determination-process/local to register to attend an Open Meeting.  For individuals not able to attend an Open Meeting, each MAC will post a recording of their Open Meeting to their respective website.  

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