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, Inc. has received a 12-month status quo designation for its products, ensuring continued reimbursement eligibility for diabetic foot ulcers (DFU) and venous leg ulcers (VLU) through 2026, while coverage for pressure ulcers remains unaffected by recent CMS updates [1][2][3][4]. Group 1: Reimbursement and Coverage - The Centers for Medicare & Medicaid Services (CMS) has categorized products into three groups: Covered, Non-Covered, and 12-Month Status Quo, allowing products in the Status Quo category to remain eligible for reimbursement as long as they meet the "reasonable and necessary" standard [2]. - The final Local Coverage Determinations (LCDs) specifically apply to DFU and VLU, not affecting payments for other wound types, thus maintaining consistent care for non-DFU/VLU patients [3]. - BioStem's largest reimbursement segment, related to pressure ulcers, remains unchanged, allowing continued use of its products without coverage interruption [3]. Group 2: Company Strategy and Future Plans - The CEO of BioStem expressed confidence that the status quo designation will ensure uninterrupted payment for its products in DFU and VLU applications throughout 2026, while also preserving access and revenue stability for the company's core pressure ulcer business [4]. - BioStem has submitted new clinical and scientific data to CMS, demonstrating the superiority of its products over standard care, and plans to engage in further discussions with CMS regarding its clinical trial findings [4]. - The company aims to transition its products from Status Quo to Covered status during the 2027 reconsideration cycle, emphasizing its commitment to generating clinical evidence and ensuring access to its placental allografts [4].