June 10, 2024

At the end of last week, APMA submitted comments to all seven Part B Medicare Administrative Contractors in conjunction with APMA’s Contractor Advisory Committee (CAC) representatives to address concerns with draft Local Coverage Determinations (LCDs) and Local Coverage Articles (LCA) related to use of skin substitute products (also referred to as Cellular and/or Tissue Based Products, or CTPs) used for the treatment of diabetic foot ulcers (DFU) and Venous Leg Ulcers (VLU).

As indicated in a previous Weekly Focus, 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. One of the proposals provided that coverage only be allowed for skin substitute grafts/CTPs that have peer-reviewed, published evidence supporting their use. Another proposal limited the number of applications to no greater than four within the episode of skin replacement therapy other than “in exceptional cases in which four applications is not sufficient for adequate wound healing.” These proposals were subject to comment. APMA and its appropriate committees, in conjunction with APMA’s national network of CAC representatives, reviewed these proposals and contributed to the preparation of APMA’s comments. APMA supported the CAC representatives in their efforts by coordinating attendance at CAC meetings, sharing bullet points for discussion, and sharing draft letters for submission by APMA in conjunction with the CAC representatives.

APMA provided comments on the following items, among others:

• Clarifying if the MACs will apply the rigid guidelines of this policy (such as the list of “Covered Products”) to non-DFU/VLU applications
• In Covered Indications, changing the word “measurable” to “significant”
• Supporting common use of JZ and JW Modifiers with this service by all 7 Part B MACs
• Requesting that the MACs’ language regarding requiring failure to respond be reconciled between 4 Weeks and 30 Days
• Under Limitations, requesting that the MACs not restrict the care for patients whose therapy also includes recurrence of the DFUs and VLUs in the same location within 12 months from initial application
• Recommending that the MACs change the word “correcting” to “optimizing” with respect to systemic causes of impaired healing
• Under Evidence-Based Guidelines for Skin Substitute Grafts/CTP, better define “Substantial ulcer improvement”

Members can read these letters, as well as all other past comment letters, at www.apma.org/CommentLetters. If you have questions or concerns, contact the APMA Health Policy and Practice department at healthpolicy.hpp@apma.org.

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