BioStem Technologies Products Placed on “12-Month Status Quo Period” List in Update to CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes

Core Viewpoint - BioStem Technologies' products, VENDAJE® and VENDAJE AC®, have been granted a 12-month status quo period for reimbursement eligibility under the CMS CY 2026 Final Medicare Reimbursement Rule, ensuring continued access for patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU) [3][4]. Group 1: Reimbursement Status - The 12-month status quo designation allows BioStem's products to remain eligible for reimbursement in 2026, provided their use meets the "reasonable and necessary" standard [4]. - The Medicare Administrative Contractors (MACs) will review additional evidence by December 31, 2026, with updated determinations expected in early 2027 [4]. Group 2: Impact on Other Products - The final policy from CMS specifically applies to DFU and VLU indications, leaving reimbursement for other wound types, such as pressure ulcers, unaffected [5]. - Pressure ulcers represent the largest segment of the chronic wound market at 41%, which is crucial for BioStem's sales volume and Medicare-related revenue [5]. Group 3: Company Statements and Future Plans - The CEO of BioStem expressed appreciation for CMS's evidence-driven approach and anticipates uninterrupted payment for their products in DFU and VLU applications throughout 2026 [6]. - BioStem plans to engage with CMS and MACs to discuss clinical trial findings and aims to achieve reclassification of their products from Status Quo to Covered status during the 2027 reconsideration cycle [6].