Dec. 26 at 3:24 PM
Celularity Inc. reported that the Centers for Medicare & Medicaid Services (CMS) have withdrawn Local Coverage Determinations (LCDs) for skin substitutes that were set to take effect January 1, 2026. The withdrawn LCDs had maintained Medicare coverage eligibility for Celularity’s Biovance® and Biovance 3L products while removing coverage for 158 competing skin substitute products. CMS’s new payment policy, which reimburses skin substitutes at a fixed rate of
$127.28 per square centimeter, remains in effect.
CEO Dr. Robert J. Hariri noted that Celularity has “substantial real-world evidence” supporting the effectiveness of its Biovance® human amniotic membrane allograft for wound healing and highlighted that the company’s manufacturing process, established since Biovance®’s commercial launch in April 2014, allows it to operate effectively under the new Medicare reimbursement framework.
$CELU