Legacy coverage remains in place as Kerecis continues to lead under evolving Medicare payment models

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by the U.S. Centers for Medicare & Medicaid Services (CMS) that its A/B Medicare Administrative Contractors (MACs) have withdrawn the proposed Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products in the outpatient setting.

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MariGen packaging photo courtesy of Kerecis

The withdrawn LCDs, that were just recently updated on December 15^th and scheduled to take effect on January 1, 2026, would have introduced coverage limitations to certain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 The withdrawn LCDs covered diabetic foot ulcers and venous leg ulcers but would not have covered other wound types.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:

• Legacy LCDs across MACs such as CGS, Novitas, and FCSO continue unchanged. Palmetto, NGS, WPS, and Noridian remain without an active LCD.
• The previously announced $127/cm² fixed payment rate will still take effect on January 1, 2026.
• Coverage for additional wound types, including pressure ulcers and surgical wounds that have failed 30 days of conservative care, remains available.
• The maximum application frequency remains 10 applications, rather than the reduced limit proposed in the withdrawn LCDs.

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.

“We have built Kerecis to win in the real-world clinical and reimbursement environment,” said Fertram Sigurjonsson, Coloplast EVP of Wound & Tissue Repair and CEO of Kerecis. “While others scramble to restructure their pricing or fight coverage: our fish-skin technology, pricing discipline, and broad coverage position make us a safe harbor for providers today and a strong competitor as the market continues to change.”

Kerecis remains focused on expanding access, supporting clinicians, and advancing tissue regeneration through its fish-skin platform.

About Kerecis

Kerecis, founded by Fertram Sigurjonsson, develops intact fish tissue derived products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body’s own processes to heal and regenerate. Because no viral or prion transfer risk exists between Atlantic cod and humans, Kerecis products are only gently processed and retain their similarity to human tissue. The gentle processing preserves the material’s original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies show that Kerecis products heal wounds faster than competitors. Kerecis is the only global manufacturer of medical devices containing intact fish-tissue and is the fastest growing company in the U.S. xenograft biologics skin market. Products include SurgiBind®/SurgiClose®, GraftGuide®, MariGen®, and Shield™ for various medical applications. Committed to the UN Sustainable Development Goals, Kerecis uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products. For more information about Kerecis and its clinical research, visit www.kerecis.com.

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Kerecis remains focused on expanding access, supporting clinicians, and advancing tissue regeneration through its fish-skin platform.