ARLINGTON, Va. & REYKJAVIK, Iceland– Kerecis, a company known for its use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration, has welcomed the decision by the Centers for Medicare & Medicaid Services (CMS) to delay the implementation of its proposed Local Coverage Determination (LCD) for Skin Substitute Grafts/Cellular and Tissue-Based Products. The new effective date for the policy will be January 1, 2026.
The company’s products remain fully covered under existing Medicare policies, supported by strong clinical evidence. Kerecis’ fish-skin grafts have demonstrated exceptional results in treating chronic and complex wounds, including those with exposed bone and tendon.
Current Coverage Policies Remain in Place Until 2026
With the LCD not yet finalized, existing Medicare Administrative Contractor (MAC)-specific coverage policies will remain in effect through 2025. This includes broad coverage under the Novitas and FCSO LCDs for products with proven clinical effectiveness. In regions without specific LCDs, the standard of “reasonable and necessary” will continue to apply.
As concerns over the use of skin substitutes increase, especially due to recent audit activity, healthcare providers can expect more scrutiny on documentation and the clinical rationale behind product choices. Kerecis supports CMS’s emphasis on evidence-based care and continues to lead through rigorous clinical research and responsible product use.
Delay Offers Kerecis Opportunity to Share More Clinical Evidence
The postponement follows an administrative review process as part of the transition to a new CMS administration. Kerecis sees this delay as a chance to provide updated clinical evidence, including data from recent studies on venous leg ulcers, ischemic ulcers, post-Mohs wounds, and pressure ulcers.
Fertram Sigurjonsson, Founder and CEO of Kerecis, said, “The postponement gives us a valuable opportunity to share additional clinical data, including results from the largest skin substitute randomized controlled trial on diabetic foot ulcers with exposed bone or tendon to date. It also allows us to present findings on our latest product innovations.”
Kerecis remains dedicated to working with CMS to support policies that prioritize patient outcomes and the use of clinically validated products. The company, founded by Fertram Sigurjonsson, specializes in developing fish skin and fatty acid products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged tissue, these patented materials support the body’s natural healing processes.
Because there is no risk of disease transfer between cold-water fish and humans, Kerecis fish-skin is processed gently to retain its similarity to human tissue. This careful processing preserves the skin’s three-dimensional structure, maintaining its natural strength and complexity, including key molecules like fatty acids. Clinical studies have shown that Kerecis products help wounds heal faster than competing products.
Kerecis is the only global manufacturer of medical devices containing intact fish skin and is the fastest-growing company in the U.S. biologics skin market. Its product line includes SurgiBind®/SuriClose®, GraftGuide®, MariGen®, and Shield™ for various medical applications. The company is committed to the UN Sustainable Development Goals and uses sustainably sourced Icelandic fish processed with renewable energy.
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