Organogenesis Applauds CMS’s Significant Step In Payment Reform
Organogenesis (Nasdaq: ORGO) applauded CMS’s finalization of payment reform for skin substitutes/CTPs under the CY 2026 Physician Fee Schedule announced Nov. 3, 2025.
The company highlighted that CMS finalized FDA classifications and a per centimeter-square payment methodology for both physician office and hospital outpatient settings, and said CMS recognized the clinical differentiation of PMA products, which the company believes will increase access and support higher payment and expanded access for PMA technologies. Organogenesis reiterated its multi-decade leadership and said its evidence-based portfolio positions it well for the skin substitutes market in 2026 and beyond.
The release contains forward-looking statements and cautions that actual outcomes are subject to risks and uncertainties described in the company’s SEC filings.
Organogenesis (Nasdaq: ORGO) ha elogiato la finalizzazione da CMS della riforma dei pagamenti per i sostituti della pelle/CTP nell'CY 2026 Physician Fee Schedule annunciata il 3 novembre 2025.
L'azienda ha evidenziato che CMS ha finalizzato classificazioni FDA e una metodologia di pagamento per ogni centimetro quadrato sia per l'ambulatorio medico che per l'ospedale ambulatorio, e ha dichiarato che CMS ha riconosciuto la differenziazione clinica dei prodotti PMA, che l'azienda ritiene aumenterà l'accesso e sosterrà pagamenti più elevati e una maggiore accessibilità per le tecnologie PMA. Organogenesis ha ribadito la sua leadership pluridecennale e ha detto che il suo portafoglio basato su evidenze la posiziona bene per il mercato dei sostituti della pelle nel 2026 e oltre.
Il comunicato contiene dichiarazioni anticipatorie e avverte che gli esiti effettivi sono soggetti a rischi e incertezze descritti nei rendimenti SEC della società.
Organogenesis (Nasdaq: ORGO) aplaudió la finalización por parte de CMS de la reforma de pagos para sustitutos de piel/CTPs bajo el CY 2026 Physician Fee Schedule anunciada el 3 de noviembre de 2025.
La compañía destacó que CMS finalizó clasificaciones de la FDA y una metodología de pago por centímetro cuadrado tanto para consultorios médicos como para entornos ambulatorios hospitalarios, y dijo que CMS reconoció la diferenciación clínica de los productos PMA, lo que la empresa cree que aumentará el acceso y apoyará pagos más altos y un mayor acceso para tecnologías PMA. Organogenesis reiteró su liderazgo durante décadas y dijo que su cartera basada en evidencia la posiciona bien para el mercado de sustitutos de piel en 2026 y más allá.
El comunicado contiene declaraciones prospectivas y advierte que los resultados reales están sujetos a riesgos e incertidumbres descritos en los registros 1‑K/SEC de la empresa.
Organogenesis (나스닥: ORGO)가 피부 대체물/CTP에 대한 지불 개혁을 CY 2026 Physician Fee Schedule에 따라 확정했다는 CMS의 발표를 환영했다(2025년 11월 3일).
회사는 CMS가 FDA 분류와 평방 센티미터당 지불 방법을 의사 사무실 및 병원 외래 진료 환경 모두에 대해 확정했다고 강조했으며, CMS가
이 보도 자료에는 미래 지향적 진술이 포함되어 있으며 실제 결과는 회사의 SEC 제출 자료에 설명된 위험 및 불확실성의 영향을 받는다고 경고한다.
Organogenesis (Nasdaq: ORGO) a salué la finalisation par CMS de la réforme des paiements pour les substituts cutanés/CTP dans le CY 2026 Physician Fee Schedule annoncée le 3 novembre 2025.
L’entreprise a souligné que CMS a finalisé les classifications FDA et une méthodologie de paiement au centimètre carré pour les environnements des cabinets médicaux et des services externes hospitaliers, et a déclaré que CMS a reconnu la différenciation clinique des produits PMA, ce qui, selon elle, augmentera l’accès et soutiendra des paiements plus élevés et un accès élargi pour les technologies PMA. Organogenesis a réitéré son leadership de longue date et a déclaré que son portefeuille fondé sur des preuves la positionne bien pour le marché des substituts cutanés en 2026 et au-delà.
Le communiqué contient des déclarations prospectives et avertit que les résultats réels sont soumis à des risques et incertitudes décrits dans les dépôts SEC de la société.
Organogenesis (Nasdaq: ORGO) hat die Finalisierung der Abrechnungsreform durch CMS für Hautersatzstoffe/CTPs im CY 2026 Physician Fee Schedule angekündigt am 3. November 2025 begrüßt.
Das Unternehmen hob hervor, dass CMS FDA‑Klassifikationen und eine Bezahlung pro Zentimeterquadrat sowohl für ärztliche Praxen als auch für Hospital Outpatient Settings finalisiert hat, und sagte, CMS habe die klinische Unterscheidung von PMA‑Produkten anerkannt, was das Unternehmen für eine Steigerung des Zugangs und eine Unterstützung höherer Zahlungen sowie eines erweiterten Zugangs für PMA‑Technologien hält. Organogenesis bekräftigte seine jahrzehntelange Führungsrolle und sagte, dass sein evidenzbasiertes Portfolio es gut positioniert, um 2026 und darüber hinaus im Markt für Hautersatzstoffe erfolgreich zu sein.
Die Veröffentlichung enthält zukunftsgerichtete Aussagen und warnt, dass die tatsächlichen Ergebnisse Risiken und Unsicherheiten unterliegen, wie sie in den SEC‑Unterlagen des Unternehmens beschrieben sind.
Organogenesis (ناسداك: ORGO) أشادت باكتمال CMS لإصلاحات الدفع لاستبدالات الجلد/CTPs وفقًا لـ CY 2026 Physician Fee Schedule المعلن عنها في 3 نوفمبر 2025.
أكدت الشركة أن CMS أتمت تصنيفات FDA و< b>طريقة الدفع لكل سنتيمتر مربع لكلا الإعدادين: عيادة الطبيب ومرفق الرعاية الخارجية بالمستشفى، وقالت أن CMS اعترفت بالتمييز السريري لـ منتجات PMA، وهو ما تعتقد الشركة أنه سيزيد من الوصول ويدعم دفعاً أعلى ووصولاً موسعاً لتقنيات PMA. كرّرت Organogenesis قيادتها التي تمتد لعقود وأشارت إلى أن محفظتها المعتمدة على الأدلة تضعها في موقع جيد لسوق استبدالات الجلد في 2026 وما بعدها.
يحتوي البيان على تصريحات مستقبلية وتحذر من أن النتائج الفعلية عرضة للمخاطر والشكوك الموضحة في ملفات الشركة لدى SEC.
- CMS finalized per centimeter-square payment methodology for CY 2026
- CMS recognized PMA clinical differentiation, enabling potential higher payment
- Organogenesis states it has a diverse evidence-based portfolio across FDA categories
- Outcomes remain forward-looking and subject to risks cited in the company’s 2024 10-K
- No quantified financial impact or guidance provided for CY 2026 policy changes
Insights
CMS final rule formalizes per-centimeter payment and FDA-based classifications for skin substitutes, likely improving access and reimbursement for PMA products in
Organogenesis benefits because the rule ties payments to FDA classifications and a per-centimeter squared methodology, which should raise reimbursement for higher-classified PMA products and align payment with product characteristics. This mechanism reduces unit‑price distortions under the old system and directly affects revenue per treated wound when PMA products are used.
The outcome depends on implementation details and provider adoption; utilization patterns, coding consistency, and CMS enforcement will determine realized revenue gains. The company’s statements cite expanded access and higher payment for PMA products, but actual impact will follow claims volume shifts and payer interactions outside the Medicare final rule.
Watch CMS guidance and local coverage decisions during the first quarters of
With evidence-based portfolio including technologies in each FDA category, we believe we are best positioned in the skin substitutes market for 2026 and beyond
CANTON, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, applauds the Centers for Medicare & Medicaid Services’ (CMS) significant step in payment reform for skin substitutes/cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule.
“We congratulate CMS on taking this significant step in payment reform and are pleased CMS finalized FDA classifications and a per centimeter square payment methodology in both the physician office and hospital outpatient settings,” said Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis. “We believe this new policy will increase access to PMA products while addressing abuse under the current system.”
Mr. Gillheeney continued, “We are also pleased that CMS has recognized the clinical differentiation of PMA products and taken steps toward higher payment and expanded access for PMA products. We remain committed to working with CMS and other stakeholders to further expand access to these life-saving technologies as well as incentivize investment and innovation in the space and achieve long-term market stability.”
“With more than forty years of leadership in regenerative medicine, and a diverse evidenced-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitutes market for 2026 and beyond,” concluded Mr. Gillheeney.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “will,” “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to CMS’s new payment structure and the likelihood that it will increase access to PMA products and address abuse under the current system. Forward-looking statements with respect to the operations of the Company, future growth, strategies, prospects, and other aspects of the business of the Company, including the Company’s positioning in the skin substitutes market for 2026 and beyond, are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to the risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@icrinc.com Press and Media Inquiries: Organogenesis communications@organo.com
FAQ
What did Organogenesis announce about CMS payment reform on Nov 3, 2025 for ORGO?
How does the CY 2026 payment change affect PMA products according to ORGO?
Does Organogenesis provide financial guidance tied to the CMS CY 2026 policy change?
Why does Organogenesis say it is well positioned for the skin substitutes market in 2026 (ORGO)?
What caution does Organogenesis include about the CMS announcement (ORGO)?
