BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes
Rhea-AI Summary
BioStem (OTC: BSEM) commented on CMS’s CY 2026 Physician Fee Schedule final rule reforming Medicare reimbursement for skin substitutes announced Nov 5, 2025.
BioStem said the rule creates a more transparent, predictable reimbursement framework, though the reimbursement level is lower than the company advocated. The company highlighted a Level 1 randomized controlled trial showing superior patient outcomes for its BioREtain placental allografts and said that study was submitted to CMS. BioStem also said its proprietary, vertically integrated BioREtain manufacturing delivers materially lower COGS and scalable production, and expects margins to remain robust under the new model.
Positive
- Level 1 randomized controlled trial shows superior outcomes vs standard of care
- Proprietary, vertically integrated manufacturing claims materially lower COGS
- Company expects robust product margins under new CMS reimbursement
Negative
- CMS reimbursement level is reported lower than the company advocated
News Market Reaction 1 Alert
On the day this news was published, BSEM declined 5.61%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
POMPANO BEACH, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company specializing in placental-derived biologics for advanced wound care, today commented on the Centers for Medicare & Medicaid Services’ (“CMS”) Calendar Year 2026 Physician Fee Schedule (PFS) final rule, which reforms Medicare reimbursement for skin substitutes.
“CMS’s final rule represents a decisive step toward a more transparent, predictable, and sustainable reimbursement system,” said Jason Matuszewski, Chief Executive Officer and Chairman of BioStem. “For years, we have supported thoughtful reform in this category to ensure patients receive clinically proven, high-quality products while curbing the misuse and inefficiencies that have burdened the healthcare system. While the reimbursement level is lower than we initially advocated, this framework lays the foundation for a healthier, evidence-driven market.”
The new reimbursement model follows a period of rapid growth in national spending on skin substitutes and reflects CMS’s intent to restore market balance and reward clinical performance rather than pricing variability. BioStem noted that its BioREtain®-processed placental allografts align precisely with these goals, as recently evidenced in its published Level 1 randomized controlled trial demonstrating superior patient outcomes compared to standard of care. This study was submitted to CMS to support coverage decisions and underscores BioStem’s commitment to scientific validation and responsible innovation.
In addition to its clinical advantages, BioStem emphasized that the BioREtain manufacturing process delivers structurally efficient economics. The Company’s proprietary processing methods and vertically integrated manufacturing allow for materially lower cost of goods sold (COGS) and scalable production. As a result, BioStem expects product margins to remain robust under the new CMS reimbursement model.
“We believe BioStem is exceptionally well-positioned to thrive in this environment,” added Matuszewski. “Our combination of clinically validated products, advanced GMP-compliant manufacturing, and efficient cost structure enables us to compete effectively even as the industry transitions to standardized reimbursement. We anticipate that CMS’s reforms will accelerate provider adoption of technology like BioREtain that delivers proven outcomes and economic value.”
BioStem continues to collaborate with clinical partners, policymakers, and advocacy organizations to ensure the evolving reimbursement framework supports innovation, fiscal responsibility, and optimal patient care.
About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established in compliance with current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and Linkedin.
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Contact BioStem Technologies, Inc.:
Website: www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342
Investor Relations:
Philip Trip Taylor, Gilmartin Group
E-Mail: ir@biostemtech.com
FAQ
What did BioStem (BSEM) announce about CMS CY 2026 reimbursement on Nov 5, 2025?
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