Palmetto GBA Open Meeting on Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

Thank you for your participation in the Palmetto GBA Open Meeting on Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. This meeting provides an opportunity for stakeholders to recommend changes, submit additional evidence for consideration and present concerns regarding a proposed policy. This is also an opportunity for the MACs to ensure understanding of the LCD within the stakeholder community. We appreciate all who participated and your efforts to follow the LCD process to provide feedback to us on this important topic. We have identified there are some misunderstandings and some questions which this can offer clarification.  

• The LCD is inclusive of societal guidelines which are summarized in the societal input section of the proposed LCD. The LCD aligns with 4/5 of the guidelines detailed in the policy. The only recommendations that the LCD does not follow utilized a less robust methodology for grading of the evidence.
• There are no pathways for coverage in the proposed LCD based on FDA Regulatory processes
• The policy intentionally does not limit consideration for coverage to specific study designs (e.g., RCTs) to allow investigators multiple options for future investigations
• While the policy does limit frequency of applications to 4, there is a clear pathway for use of additional applications or time when medically necessity
• Since this is an evidence-based policy all future evidence must be submitted through the LCD Reconsideration process. MACs cannot add new codes to the B&C article that expand coverage without going through the process. All effort to review new literature and add codes in a timely manner will be made.
• Any literature that was not included in the evidence review or new literature that has been published can be submitted to the MACs during the open comment period for consideration. Literature must be published in a peer-reviewed journal.
• An episode of skin replacement therapy as defined in the policy is 12 weeks from the first application of a skin substitute graft/CTP
• The policy addresses DFUs and VLUs the use of skin substitute or CPTs outside of these diagnoses are at MAC discretion

The comment period is open until June 8, 2024, and response to comments will be published with the final LCD. We hope this provides clarification in the interim regarding the intent of the policy to ensure understanding as we continue to work with the provider and stakeholder community to provide the best quality care to the Medicare beneficiaries.