CMS Delays Skin Substitute Policy, Intact Fish-Skin Grafts Remain Covered on Existing LCDs

Arlington, Va. and Reykjavik, Iceland – April 14, 2025 – Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration, welcomes the recent decision by the Centers for Medicare & Medicaid Services (CMS) to postpone the effective date of the proposed Local Coverage Determination (LCD) for Skin Substitute Grafts/Cellular and Tissue-Based Products. The new implementation date is January 1, 2026.
Kerecis products remain fully covered under existing Medicare policies and are supported by strong clinical evidence. Kerecis intact fish-skin grafts have shown exceptional outcomes across a range of chronic and complex wounds, including those with exposed bone and tendon.
With the proposed LCDs not finalized, current MAC-specific coverage policies will remain in place through 2025. This includes broad coverage under the Novitas and FCSO LCDs for products with demonstrated clinical effectiveness. In jurisdictions without specific LCDs, the standard of “reasonable and necessary” continues to apply.
As scrutiny around skin substitute utilization increases, particularly in light of recent audit activity, providers should expect greater attention to documentation and the clinical justification for product selection. Kerecis supports CMS’s focus on evidence-based care and continues to distinguish itself through rigorous clinical research and responsible product use.
The decision to postpone follows an administrative review process associated with the transition to a new CMS administration. Kerecis views this delay as an opportunity to contribute updated clinical evidence, including findings from recent studies on venous leg ulcers, ischemic ulcers, post-Mohs wounds, and pressure ulcers.