Organogenesis Applauds CMS Proposal to Reform Skin Substitute Payment Policy; Urges Refinements to Ensure Patient Access to Appropriate Products and Continued Innovation
Organogenesis (Nasdaq: ORGO), a regenerative medicine company, has expressed support for the Centers for Medicare & Medicaid Services' (CMS) proposed new payment methodology for skin substitutes in CY 2026. The proposal introduces a per centimeter square payment system based on FDA classification across both physician office and hospital outpatient settings.
CEO Gary S. Gillheeney highlighted that the new structure aims to reduce system abuse and Medicare spending while ensuring consistent payment across care sites. The proposal notably recognizes PMA products' clinical differentiation and seeks to expand access to innovative wound healing technologies that help reduce amputations and complications.
Organogenesis (Nasdaq: ORGO), un'azienda di medicina rigenerativa, ha espresso il proprio sostegno alla nuova metodologia di pagamento proposta dai Centers for Medicare & Medicaid Services (CMS) per i sostituti cutanei nel 2026. La proposta introduce un sistema di pagamento per centimetro quadrato basato sulla classificazione FDA, applicabile sia negli studi medici che negli ambulatori ospedalieri.
Il CEO Gary S. Gillheeney ha sottolineato che la nuova struttura mira a ridurre gli abusi del sistema e la spesa Medicare, garantendo al contempo un pagamento uniforme tra i diversi luoghi di cura. La proposta riconosce in particolare la differenziazione clinica dei prodotti PMA e punta ad ampliare l'accesso a tecnologie innovative per la guarigione delle ferite, contribuendo a ridurre amputazioni e complicazioni.
Organogenesis (Nasdaq: ORGO), una empresa de medicina regenerativa, ha expresado su apoyo a la nueva metodología de pago propuesta por los Centers for Medicare & Medicaid Services (CMS) para los sustitutos cutáneos en el año fiscal 2026. La propuesta introduce un sistema de pago por centímetro cuadrado basado en la clasificación de la FDA, aplicable tanto en consultorios médicos como en entornos hospitalarios ambulatorios.
El CEO Gary S. Gillheeney destacó que la nueva estructura busca reducir el abuso del sistema y el gasto de Medicare, asegurando al mismo tiempo un pago consistente en los diferentes sitios de atención. La propuesta reconoce especialmente la diferenciación clínica de los productos PMA y pretende ampliar el acceso a tecnologías innovadoras para la curación de heridas que ayudan a reducir amputaciones y complicaciones.
Organogenesis (나스닥: ORGO)는 재생 의학 회사로서 2026 회계연도 피부 대체재에 대한 CMS(Centers for Medicare & Medicaid Services)의 새로운 지불 방식 제안에 지지를 표명했습니다. 이 제안은 FDA 분류를 기반으로 한 제곱센티미터당 지불 시스템을 의사 진료실과 병원 외래 환경 모두에 도입합니다.
CEO Gary S. Gillheeney는 새로운 구조가 시스템 남용과 메디케어 지출을 줄이는 동시에 치료 장소 간 일관된 지불을 보장하는 것을 목표로 한다고 강조했습니다. 이 제안은 특히 PMA 제품의 임상적 차별성을 인정하며 절단 및 합병증 감소에 도움을 주는 혁신적인 상처 치유 기술에 대한 접근성을 확대하려고 합니다.
Organogenesis (Nasdaq : ORGO), une entreprise de médecine régénérative, a exprimé son soutien à la nouvelle méthodologie de paiement proposée par les Centers for Medicare & Medicaid Services (CMS) pour les substituts cutanés en 2026. La proposition introduit un système de paiement au centimètre carré basé sur la classification de la FDA, applicable aussi bien dans les cabinets médicaux que dans les services ambulatoires hospitaliers.
Le PDG Gary S. Gillheeney a souligné que cette nouvelle structure vise à réduire les abus du système et les dépenses Medicare, tout en garantissant un paiement cohérent entre les différents lieux de soins. La proposition reconnaît notamment la différenciation clinique des produits PMA et cherche à élargir l'accès aux technologies innovantes de cicatrisation des plaies, contribuant à réduire les amputations et les complications.
Organogenesis (Nasdaq: ORGO), ein Unternehmen für regenerative Medizin, hat seine Unterstützung für die vom Centers for Medicare & Medicaid Services (CMS) vorgeschlagene neue Zahlungsmethodik für Hautersatzstoffe im Jahr 2026 zum Ausdruck gebracht. Der Vorschlag führt ein Zahlungssystem pro Quadratzentimeter ein, das auf der FDA-Klassifizierung basiert und sowohl in Arztpraxen als auch in ambulanten Krankenhausumgebungen gilt.
CEO Gary S. Gillheeney betonte, dass die neue Struktur darauf abzielt, Missbrauch im System und Medicare-Ausgaben zu reduzieren und gleichzeitig eine einheitliche Bezahlung über verschiedene Versorgungsorte hinweg sicherzustellen. Der Vorschlag erkennt insbesondere die klinische Differenzierung von PMA-Produkten an und will den Zugang zu innovativen Wundheilungstechnologien erweitern, die Amputationen und Komplikationen reduzieren helfen.
- None.
- Current system facing issues with abuse and rapid Medicare spending escalation
- Payment structure requires further refinement to ensure long-term stability
Insights
CMS's proposed per-square-cm payment model for skin substitutes would benefit Organogenesis by creating payment stability across care settings while recognizing premium products.
The Centers for Medicare & Medicaid Services (CMS) has proposed a significant reform to how skin substitutes and cellular/tissue-based products (CTPs) are reimbursed for 2026. The proposal introduces a per centimeter square payment methodology based on FDA classification, standardizing payments across both physician offices and hospital outpatient settings.
This represents a fundamental shift from the current reimbursement approach, which Organogenesis suggests has been subject to abuse and contributed to rapidly escalating Medicare spending. The new structure would create payment consistency across different care sites while potentially controlling costs.
Most importantly for Organogenesis, CMS has acknowledged clinical differentiation between product types, particularly recognizing the value of PMA (Premarket Approval) products—typically the highest regulatory classification requiring the most rigorous clinical evidence. This distinction would expand access to premium wound healing technologies that have demonstrated efficacy in reducing amputations and complications.
Organogenesis appears strategically well-positioned for this policy change with its diverse portfolio spanning multiple FDA categories. Their decades of experience in regenerative medicine provides stability as they navigate this market evolution. However, the company's advocacy for refinements suggests the proposal may still require adjustments to optimize patient access while ensuring sustainable economics for manufacturers and providers.
While expressing support for the overall direction, Organogenesis is clearly engaging in the policy development process to ensure the final implementation properly values innovative products and maintains incentives for continued advancement in wound care technology.
CANTON, Mass., July 15, 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) proposed new payment approach for skin substitutes/cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule and urges CMS to establish 2026 payment rates based on clinical value and relative cost.
“We are pleased CMS is proposing a per centimeter square payment methodology based on FDA classification for skin substitutes in both the physician office and hospital outpatient department settings,” said Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis. “We believe this new payment structure will curb abuse under the current system, and the resulting rapid escalation in Medicare spending, while ensuring a much-needed consistent payment approach across sites of care. We are also pleased CMS has recognized the clinical differentiation of PMA products and has taken steps to expand access to these innovative wound healing technologies to ensure patients receive the most appropriate therapy, which have been proven to reduce life-threatening amputations and complications.”
Mr. Gillheeney continued, “With more than forty years of leadership in regenerative medicine, and a diverse portfolio with technologies in each FDA category, we believe we are well-positioned for future growth in an evolving wound care market. We remain committed to working with CMS and other stakeholders to further refine the proposed policies to promote long-term stability and continue to expand access to PMA products that patients need and deserve, all while reducing the overall cost to Medicare.”
About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.
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’ new payment structure and the likelihood that it will curb abuse, slow the rapid escalation in Medicare spending and ensure a consistent payment approach across sites of care, as well as expectations regarding separate 2026 payment rates based on clinical value and relative cost, all of which could benefit the Company. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company 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.
About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.
Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@icrinc.com Press and Media Inquiries: Organogenesis communications@organo.com
FAQ
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