Celularity Applauds CMS Delay of Medicare LCD for Skin Substitute Coverage

Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, has welcomed the decision by the Centers for Medicare & Medicaid Services (CMS) to revise the effective date of the Medicare Local Coverage Determination (LCD) for "Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers" to January 1, 2026.

The LCD was initially published in November 2024 and is a determination by a Medicare Administrative Contractor (MAC) on whether to cover a particular service for Medicare recipients across defined geographic areas. The recent action by CMS follows an executive order by President Trump in January 2025, which froze all regulatory guidance not yet in effect, including the Biden-era LCD. As a result, the effective date of the LCD was delayed from February 12, 2025, to April 13, 2025, and now has been extended to January 1, 2026, across all MAC jurisdictions.

“We applaud CMS Administrator Dr. Mehmet Oz for his leadership in ensuring continued access to critical wound care treatments for Medicare patients suffering from diabetic foot ulcers and venous leg ulcers,” said Dr. Robert J. Hariri, Chairman and CEO of Celularity. “This action prevents a potential healthcare crisis for diabetic Americans, as access to skin substitute treatments is essential in preventing complications like sepsis, amputations, and even premature death. We support payment system reform that ensures lower healthcare costs without compromising access to care for Medicare patients.”

Dr. Stephen Brigido, President of Degenerative Diseases at Celularity, emphasized, “Innovative skin substitute products play a critical role in improving outcomes for patients with chronic wounds. This decision preserves patient access and provides CMS time to work with stakeholders on payment system improvements based on three key principles: ensuring Medicare patient access to necessary treatments, fairly reimbursing providers, and incentivizing innovation that reduces long-term Medicare costs.”

The revised effective date allows CMS time to collaborate with stakeholders to develop a payment system that promotes both access and innovation while controlling costs.