Medicare Coverage Updates on Skin Substitutes

On Friday, January 24, 2025, all seven Medicare Administrative Contractors (MACs) announced a delay in implementing final skin substitute Local Coverage Determinations (LCDs). Initially set to take effect on February 12, 2025, the implementation date has been postponed to April 13, 2025.

When implemented, these LCDs will introduce new evidentiary requirements, restricting coverage to a small number of products while excluding many products that have historically been covered and are currently being used consistent with Food and Drug Administration (FDA) requirements.

AATB had previously requested a one-year delay to these LCDs and requested the Centers for Medicare and Medicaid Services (CMS) and the MACs to establish an expedited process for moving products from the noncovered list to the covered list.

Next week, dozens of AATB members will take their advocacy to Capitol Hill, seeking a further delay and pushing for revisions to the policy. These changes aim to provide companies additional time to conduct clinical trials and publish evidence for coverage in peer-reviewed journals, ensuring continued access to essential products for patients in need.