Celularity CEO Comments on Centers for Medicare & Medicaid Services’ Withdrawal of Skin Substitute Local Coverage Determinations

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[{"type":"text","content":"While Celularity’s Biovance® and Biovance 3L products remained eligible for Medicare coverage under the now-withdrawn LCDs, Celularity CEO Dr. Robert J. Hariri welcomed the recent action taken under the leadership of CMS Administrator Dr. Mehmet Oz","length":248,"tagName":"p"},{"type":"text","content":"FLORHAM PARK, N.J., Dec. 26, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today released comments by Robert J. Hariri, M.D., Ph.D., CEO and Chairman, on the Centers for Medicare & Medicaid Services’ (CMS) recent withdrawal of skin substitute Local Coverage Determinations (LCDs) that were set to go into effect on January 1, 2026.","length":456,"tagName":"p"},{"type":"text","content":"On December 24, 2025, CMS announced that effective immediately, A/B Medicare Administrative Contractors (MACs) were withdrawing the LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers scheduled to become effective on January 1, 2026. The LCDs, adopted under an earlier Medicare 2026 Skin Substitute Update, set which skin substitute products would be eligible for Medicare coverage beginning in 2026. While Celularity’s Biovance® and Biovance 3L remained eligible for Medicare coverage under the now-withdrawn LCDs, Medicare coverage was eliminated for 158 skin substitute products sold by other companies. Unaffected by CMS’ recent action is its new payment policy that effective January 1, 2026, all skin substitute applications furnished in physician office settings and hospital outpatient department settings will be paid at a flat rate of $127.28 per square centimeter.","length":954,"tagName":"p"},{"type":"text","content":"Commenting on the recent change, Dr. Hariri said, “We have amassed substantial real-world evidence, or RWE, from multiple studies showing how our Biovance® Human Amniotic Membrane Allograft works in actual clinical practice for wound healing, demonstrating its effectiveness in diverse, real-life diverse patient populations patients with chronic wounds. RWE from large observational studies published in the peer-reviewed journal WOUNDS and elsewhere show Biovance® effectively treats chronic wounds, even in patients with multiple health issu...

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