Arlington, VA, and Reykjavik, Iceland – December 26, 2025 – Kerecis, the company pioneering the use of sustainably sourced fish skin in cellular therapy and tissue regeneration, today reaffirmed the strength of its fish-skin platform following the December 24, 2025 announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) that its A/B Medicare Administrative Contractors (MACs) have withdrawn the proposed Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products in the outpatient setting.
The withdrawn LCDs, that were just recently updated on December 15th and scheduled to take effect on January 1, 2026, would have introduced coverage limitations to certain products and certain wound types. The withdrawn LCDs covered diabetic foot ulcers and venous leg ulcers but would not have covered other wound types. Their withdrawal reverts coverage back to the existing MAC LCDs, commonly referred to as the Legacy Policies.
Under the current framework:
Kerecis has built its outpatient Medicare business operating under the Legacy Policies, establishing a strong and defensible market position. With an average outpatient Medicare price of approximately $110/cm², Kerecis’ fish-skin grafts are well aligned with the upcoming fixed payment structure, reinforcing the company’s ability to compete effectively as reimbursement models evolve. Kerecis strong body of evidence makes it ready for any new coverage rules that might emerge from this.
Kerecis remains focused on expanding access, supporting clinicians, and advancing tissue regeneration through its fish-skin platform.
From the town of Ísafjörður in northwest Iceland, Kerecis develops, manufactures, and distributes patented fish-skin medical devices that support soft tissue regeneration in the body, with regulatory clearance in the United States, Europe, and beyond.
