BioStem Secures 2026 Medicare Reimbursement Bridge Under CMS Status Quo Rule
BioStem Technologies has avoided an immediate reimbursement cliff after the Centers for Medicare & Medicaid Services (CMS) placed its lead placental-derived wound products into a 12-month “status quo” category under the agency’s finalised CY 2026 Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products.
The designation allows VENDAJE® and VENDAJE AC® to remain eligible for Medicare reimbursement for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) throughout 2026, preserving patient access while CMS and its Medicare Administrative Contractors (MACs) continue to evaluate additional clinical evidence. The updated LCDs take effect January 1, 2026.
What You Need To Know
- VENDAJE and VENDAJE AC retain DFU/VLU reimbursement through 2026
- Status quo category allows claim-by-claim payment pending review
- Pressure ulcer reimbursement unaffected by CMS LCD changes
- Reconsideration cycle set for early 2027 following evidence submission
Under CMS’s final framework, skin substitute products were stratified into three reimbursement pathways: Covered, Non-Covered, and 12-Month Status Quo. Products assigned to the status quo group remain payable on a claim-by-claim basis, provided they meet the statutory “reasonable and necessary” standard under Section 1862(a)(1)(A) of the Social Security Act and other applicable billing requirements.
The status quo category functions as a transitional mechanism, allowing products with emerging or evolving evidence to remain in clinical use while manufacturers submit additional data. CMS indicated that MACs will initiate a formal LCD reconsideration after 12 months, with manufacturers required to submit updated evidence by December 31, 2026. Revised coverage determinations are expected in early 2027.
CMS clarified that the final LCDs apply only to DFU and VLU indications. Payment for other wound types, including pressure ulcers, remains unaffected. Pressure ulcers represent the largest segment of the chronic wound market, accounting for approximately 41% of cases, and comprise the majority of BioStem’s Medicare-related revenue. As a result, the company’s largest reimbursement exposure remains fully intact, and existing billing workflows for providers do not change.
Company leadership framed the outcome as a stability win amid a volatile reimbursement reset that has disrupted large portions of the advanced wound care market.
BioStem said it submitted new clinical and scientific data to CMS and the MACs ahead of the November evidence deadline, including results from a recent DFU study demonstrating statistical superiority over standard of care. The company plans to continue engagement with CMS during 2026 to review those findings and to provide updates from its ongoing VLU clinical trial, positioning VENDAJE and VENDAJE AC for potential reclassification to Covered status in the 2027 review cycle.
The decision underscores CMS’s increasingly evidence-tiered approach to skin substitute reimbursement, where continued access is no longer binary but staged, contingent on real-world data generation and formal reassessment. For manufacturers, the status quo category offers temporary commercial continuity, but also imposes a clear deadline to deliver higher-quality outcomes data.
The designation avoids abrupt therapy disruption in DFU and VLU care during 2026, while maintaining broader access across non-DFU wound indications.