April 29, 2024

Updated May 13, 2024

Over the past couple of weeks, APMA has been coordinating with our Contractor Advisory Committee (CAC) representatives to address challenges brought about by proposed skin substitutes/ cellular and/or tissue-based products (CTPs) for Diabetic Foot Ulcers (DFU) and Venous Leg Ulcers (VLU) Local Coverage Determinations (LCDs) released in April. APMA is supporting the CAC representatives in their efforts by coordinating attendance at upcoming CAC meetings, sharing bullet points for discussion, and sharing draft letters for submission by APMA in conjunction with the CAC representatives. APMA has prioritized this issue within Health Policy and has had numerous discussions with external and internal consultants and APMA health policy and organization leadership. While there may be some issues in the details of these policies that could impact beneficiary care, we do acknowledge that they do address a number of the concerns we stated in our previous letters to CMS and the MACs on these policies.

On April 25, all 7 Part B MACs in the country released identical Proposed LCDs and accompanying Proposed LCAs for the use of skin substitutes/CTPs for treating DFUs and VLUs. These are only proposals that are now subject to comment. APMA and its appropriate committees are reviewing these proposals and preparing to submit comments.

One of the proposals is that coverage only be allowed for skin substitute grafts/CTPs that have peer-reviewed, published evidence supporting their use. More specific product requirements are listed in the proposed policies. Another proposal is to not allow greater than four applications of a skin substitute graft/CTP within the episode of skin replacement therapy other than “in exceptional cases in which four applications is not sufficient for adequate wound healing.” View an example of one of these policies (which is identical for all seven MACs).

APMA will keep you posted on developments as they arise.

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