Advocacy Win on Skin Substitutes!

On November 14, all seven Part B Medicare Contractors released final local coverage determinations (LCDs) that will govern the provision of skin substitute grafts/cellular and tissue-based products to Medicare Part B beneficiaries when used for the treatment of diabetic foot ulcers and venous leg ulcers. These policies take effect February 12, 2025.

Following APMA advocacy and APMA's response to the initial, proposed version of this policy, there are several improvements in the final version compared to what was initially proposed. APMA is reviewing the details of this policy; in the meantime, some highlights include:

• The proposed requirement to perform an ankle-brachial index was modified to instead require a "vascular assessment."
• The proposed policy called for limiting the number of skin substitute applications per episode of care to four. APMA contested this limit, and the final policy allows a maximum of eight skin substitute graft/CTP applications within an episode of skin replacement therapy (defined as 12 to 16 weeks from the first application of a skin substitute graft/CTP) when there is documentation of progression of wound closure under the current treatment plan with documented medical necessity for additional applications. When more than four medically necessary applications are performed, the KX Modifier must be used to indicate the medical necessity of this number of applications.
• Skin substitute products/CTPs with labeled indications for use over exposed muscle, tendon, or bone will be allowed over exposed muscle, tendon, or bone in the absence of contraindications.
• When all criteria in the policy are met, skin substitute/CTP application will be allowed for chronic, non-infected diabetic foot ulcers that have failed to achieve at least 50 percent ulcer area reduction with the standard of care that is outlined in the policy for a minimum of four weeks with documented compliance.
• When all criteria in the policy are met, skin substitute/CTP application will be allowed for chronic, non-infected venous leg ulcers that have failed to respond to the standard of care that is outlined in the policy for a minimum of four weeks with documented compliance.
• The policy lists 17 brand name products that are "covered for diabetic foot ulcers."
• The policy lists five brand name products that are "covered for venous leg ulcers."
• The policy lists more than 100 brand name products that are considered to be "non-covered."

APMA will continue to evaluate any issues that arise from the publication of these final LCDs and will respond as appropriate. Watch for more information about these changes and the impact for your practice.