As previously shared by APMA, all seven Part B Medicare Administrative Contractors (MACs) have finalized 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.
On April 11, 2025, all seven MACs and CMS announced an implementation delay of these policies to January 1, 2026. At the same time, CMS announced that "any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted to CMS at CAGInquiries@cms.hhs.gov by November 1, 2025” to determine if revisions to the LCD are appropriate before it takes effect.
These finalized policies reflect many of the requests made by APMA during the initial comment period, including the requirement for a vascular assessment rather than the rigid requirement of an ankle-brachial index for all patients. The finalized policies also allow a maximum of eight skin substitute graft/CTP applications within an episode of skin replacement therapy when there is documentation of progression of wound closure under the current treatment plan with documented medical necessity for additional applications. Members can read these comment letters in full on APMA's Comment Letter page.
APMA continues to closely monitor the news surrounding these polices. If anything changes, APMA will alert members. Contact the APMA Health Policy and Practice Department with any questions or concerns.