Thanks to those who submitted comments

What was the Issue?

On April 25, 2024, the Medicare Administrative Contractors (MACs) released draft Local Coverage Determinations (LCDs) and accompanying Local Coverage Billing & Coding Articles (LCAs) that will dramatically effect Medicare coverage of these products:

See: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers


In August 2023, three Medicare Administrative Contractors issued final LCDs/LCAs that would have dramatically limit access to CTPs for treatment of diabetic foot ulcers/venous leg ulcers with an implementation time frame that would have significantly jeopardized patient care. As a response to advocacy from the wound care community led by the Alliance, the MACs withdrew the policies days before their implementation date and announced that the policies would be redeveloped and reissued following additional vetting with stakeholders.

These “redeveloped” coverage policies were recently published on April 25th, 2024, and not just by three MACS (which had combined coverage-setting jurisdiction over 15 states), but by all the MACs – which essentially means that this is no longer a regional coverage issue but a national one. While the policies span a range of detailed issues, key provisions included:

  • Limited number of applications: The newly issued draft policies permit only 4 applications of CTPs in a 12-week treatment period. This is the same limitation as had been included in the policies issued (then withdrawn) last year. The key improvement is this: the policies now allow for additional applications or an extension of the 12-week period when medically necessary and documented in the patient medical record. 

  • Significant restrictions to covered products: The 2024 policies continue to place significant restrictions on the number of CTPs covered for treatment of DFU/VLU. Only 15 product HCPCS codes are accepted for coverage under these newly issued policies, based on what the MACs deem sufficient peer-reviewed evidence. Just as the 2023 policies had done, the newly issued 2024 policies remove coverage from a significant number commonly used products that are currently covered and reimbursed by Medicare with the placement of approximately 130 CTPs on the non-covered list.  

Comments Submitted 

The Alliance submitted comments by the June 8, 2024 deadline. Thanks to all who submitted comments to their MAC medical director voicing the impact the policies may have on your practice and patient care.  CMS is particularly interested in the voice and perspective of health providers. Articulating the realities and complexities of wound care helps policymakers and payers forge clinically sound policies. We will share detailed updates when the coverage policies issue as final, and outline what changed from these drafts, what didn't change, and what we believe the impact will be.

Draft LCDs and LCAs, by MAC:

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