BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes
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.
BioStem (OTC: BSEM) ha commentato la versione finale del Piano tariffario per i medici CY 2026 della CMS che riforma il rimborso Medicare per i sostituti della pelle annunciata il 5 novembre 2025.
BioStem ha affermato che la norma crea un quadro di rimborso più trasparente e prevedibile, anche se il livello di rimborso è inferiore a quanto sostenuto dall'azienda. L'azienda ha evidenziato un trial randomizzato di livello 1 che mostra esiti migliori per i suoi innesti placentari BioREtain e ha detto che lo studio è stato presentato alla CMS. BioStem ha anche detto che la sua produzione BioREtain, di proprietà, verticalmente integrata, fornisce costi delle merci vendute significativamente inferiori e una produzione scalabile, e si aspettano margini robusti anche nel nuovo modello.
BioStem (OTC: BSEM) comentó sobre la regla final del Calendario de Honorarios de Médicos CY 2026 de CMS que reforma el reembolso de Medicare para sustitutos de piel anunciada el 5 de noviembre de 2025.
BioStem dijo que la regla crea un marco de reembolso más transparente y predecible, aunque el nivel de reembolso es inferior al que la empresa defendía. La empresa señaló un ensayo aleatorizado de nivel 1 que muestra resultados superiores para sus injertos placentarios BioREtain y dijo que ese estudio fue presentado a CMS. BioStem también afirmó que su fabricación BioREtain, propiedad y verticalmente integrada, ofrece costos de bienes vendidos notablemente más bajos y producción escalable, y espera que los márgenes permanezcan sólidos bajo el nuevo modelo.
BioStem (OTC: BSEM)는 CMS의 CY 2026 의사 재정수당 일정 최종 규정에 대해 2025년 11월 5일 발표된 피부 대체물에 대한 메디케어 상환개편에 대해 코멘트했다.
BioStem은 이 규정이 더 투명하고 예측 가능한 상환 프레임워크를 만든다고 말했으며, 상환 수준이 회사가 주장한 것보다 낮다. 회사는 1등급 무작위 대조시험이 BioREtain 태반 동종 이식편에 대해 우수한 환자 결과를 보였다고 강조했으며 그 연구는 CMS에 제출되었다고 말했다. BioStem은 또한 자사 독점적이고 수직적으로 통합된 BioREtain 제조가 원가가 크게 낮다고 주장했고, 새로운 모델에서도 수익 마진이 견고하게 유지될 것으로 기대한다고 밝혔다.
BioStem (OTC: BSEM) a commenté sur la règle finale du Plan de tarification des médecins CY 2026 de la CMS, qui réformera le remboursement Medicare des substituts cutanés annoncée le 5 novembre 2025.
BioStem a dit que la règle crée un cadre de remboursement plus transparent et prévisible, bien que le niveau de remboursement soit inférieur à ce que l'entreprise préconisait. L'entreprise a mis en évidence un ESSAI randomisé de niveau 1 montrant des résultats supérieurs pour ses allogreffes placentaire BioREtain et a déclaré que cette étude a été soumise à la CMS. BioStem a également déclaré que sa fabrication BioREtain, propriétaire et verticalement intégrée, offre des coûts des marchandises vendues nettement plus bas et une production évolutive, et s'attend à ce que les marges restent robustes sous le nouveau modèle.
BioStem (OTC: BSEM) kommentierte auf die CMS-Endregelung des CY 2026 Physician Fee Schedule, die die Medicare-Erstattung für Hautersatzstoffe reformiert, angekündigt am 5. November 2025.
BioStem sagte, die Regel schaffe einen transparenteren, vorhersehbareren Erstattungsrahmen, obwohl das Erstattungsniveau niedriger ist als vom Unternehmen vorgeschlagen. Das Unternehmen hob eine Level-1-randomisierte kontrollierte Studie hervor, die überlegene Patientenergebnisse für seine BioREtain-Plazenta-Allografts zeigte, und sagte, dass diese Studie CMS vorgelegt wurde. BioStem sagte auch, dass seine eigenständige, vertikal integrierte BioREtain-Fertigung wesentlich niedrigere COGS und skalierbare Produktion liefert und erwartet, dass die Margen unter dem neuen Modell robust bleiben.
BioStem (OTC: BSEM) علّقت على القاعدة النهائية لـ CMS جدول أتعاب الأطباء لسنة CY 2026 التي تعيد تشكيل تعويض Medicare لبدائل الجلد التي أعلنت في 5 نوفمبر 2025.
قالت BioStem إن القاعدة تخلق إطار تعويض أكثر شفافية وتوقعاً، رغم أن مستوى التعويض أدنى مما طالبت به الشركة. أبرزت الشركة اختباراً عشوائياً من المستوى 1 يظهر نتائج مرضى متفوقة لزراعات BioREtain المشيمة، وقالت إن هذه الدراسة قدمت إلى CMS. كما قالت BioStem إن تصنيع BioREtain الملكي والموحد عمودياً يوفر تكاليف البيع المتداولة أقل بكثير وتوليد إنتاج واسع النطاق، وتتوقع أن تبقى الهوامش قوية بمقتضى النموذج الجديد.
- 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
- CMS reimbursement level is reported lower than the company advocated
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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