Celularity CEO Comments on CMS Withdrawal of Skin Substitute Coverage Determinations
Celularity released comments by Robert Hariri, CEO and Chairman, on the Centers for Medicare & Medicaid Services' recent withdrawal of skin substitute Local Coverage Determinations that were set to go into effect on January 1, 2026. On December 24, CMS announced that A/B Medicare Administrative Contractors 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. 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 While Celularity's Biovance and Biovance 3L remained eligible for Medicare coverage under the now-withdrawn LCDs, Medicare coverage was eliminated for 158 skin substitute products sold by other companies.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, 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. 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 issues. Other RWE shows reduced steroid use in about half of patients treated with Biovance, which evidence indicates helps decrease pro-inflammatory factors and increase anti-inflammatory ones, guiding the body's natural healing...Biovance has been supported by a highly efficient, proven scalable manufacturing process since its commercial launch in April 2014, which today allows us to operate comfortably under the new Medicare reimbursement for skin substitute products. Our sustained investment in advanced infrastructure includes a world-class GMP/GTP manufacturing facility located in Florham Park, New Jersey, where today we manufacture a range of commercial advanced biomaterial products and investigational cell therapy products, including both Celularity branded products and contract manufactured products for third parties. Consistent with our emphasis on real-world evidence gained from actual clinical use of our products, we have integrated an 'Industry 5.0' approach into our manufacturing operations, introducing digitization and AI and building adaptable and robust value chains and production systems."
