Organogenesis Supports CMS鈥� Local Coverage Determination Implementation Delay to Review Coverage Policies to Maintain Patient Access with High Quality Evidence of Effectiveness
Organogenesis Holdings (Nasdaq: ORGO) supports the U.S. Centers for Medicare & Medicaid Services' (CMS) decision to delay the implementation of local coverage determinations (LCDs) for skin substitute grafts and cellular tissue-based products (CTP) used in treating diabetic foot ulcers and venous leg ulcers.
The company endorses CMS's move to review coverage policies ensuring patient access to products with high-quality effectiveness evidence, including real-world evidence. CEO Gary S. Gillheeney Sr. recommends CMS implement an integrated coverage and payment policy to address rising Medicare costs while maintaining cost-effective patient care and innovation.
As a four-decade leader in regenerative medicine, Organogenesis pioneers bioengineered living cell products and manufactures advanced wound care therapies, with multiple technology platforms supporting clinically proven solutions that improve outcomes while reducing overall care costs.
Organogenesis Holdings (Nasdaq: ORGO) sostiene la decisione dei Centri per Medicare e Medicaid degli Stati Uniti (CMS) di posticipare l'implementazione delle determinazioni di copertura locale (LCD) per i trapianti di sostituti cutanei e i prodotti a base di tessuto cellulare (CTP) utilizzati nel trattamento delle ulcere del piede diabetico e delle ulcere venose agli arti inferiori.
L'azienda approva la mossa del CMS di rivedere le politiche di copertura per garantire l'accesso dei pazienti a prodotti con evidenze di efficacia di alta qualit脿, inclusi i dati del mondo reale. Il CEO Gary S. Gillheeney Sr. raccomanda al CMS di implementare una politica integrata di copertura e pagamento per affrontare l'aumento dei costi di Medicare, mantenendo al contempo una cura dei pazienti efficace in termini di costi e innovazione.
Come leader nel campo della medicina rigenerativa da quattro decenni, Organogenesis 猫 pioniera nella creazione di prodotti cellulari viventi bioingegnerizzati e produce terapie avanzate per la cura delle ferite, con molteplici piattaforme tecnologiche che supportano soluzioni clinicamente provate che migliorano i risultati riducendo al contempo i costi complessivi delle cure.
Organogenesis Holdings (Nasdaq: ORGO) apoya la decisi贸n de los Centros de Servicios de Medicare y Medicaid de EE. UU. (CMS) de retrasar la implementaci贸n de las determinaciones de cobertura local (LCD) para injertos de sustitutos de piel y productos basados en tejido celular (CTP) utilizados en el tratamiento de 煤lceras del pie diab茅tico y 煤lceras venosas en las piernas.
La compa帽铆a respalda el movimiento del CMS para revisar las pol铆ticas de cobertura asegurando el acceso de los pacientes a productos con evidencia de efectividad de alta calidad, incluyendo evidencia del mundo real. El CEO Gary S. Gillheeney Sr. recomienda que el CMS implemente una pol铆tica de cobertura y pago integrada para abordar el aumento de los costos de Medicare, manteniendo al mismo tiempo una atenci贸n al paciente rentable e innovadora.
Como l铆der durante cuatro d茅cadas en medicina regenerativa, Organogenesis es pionera en productos celulares vivos bioingenierizados y fabrica terapias avanzadas para el cuidado de heridas, con m煤ltiples plataformas tecnol贸gicas que respaldan soluciones cl铆nicamente probadas que mejoran los resultados mientras reducen los costos generales de atenci贸n.
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Organogenesis Holdings (Nasdaq: ORGO) soutient la d茅cision des Centres am茅ricains pour Medicare et Medicaid (CMS) de retarder la mise en 艙uvre des d茅terminations de couverture locales (LCD) pour les greffes de substituts cutan茅s et les produits 脿 base de tissus cellulaires (CTP) utilis茅s dans le traitement des ulc猫res du pied diab茅tique et des ulc猫res veineux des jambes.
L'entreprise approuve la d茅marche du CMS visant 脿 revoir les politiques de couverture afin d'assurer l'acc猫s des patients 脿 des produits disposant de preuves d'efficacit茅 de haute qualit茅, y compris des donn茅es du monde r茅el. Le PDG Gary S. Gillheeney Sr. recommande au CMS de mettre en 艙uvre une politique int茅gr茅e de couverture et de paiement pour faire face 脿 l'augmentation des co没ts de Medicare tout en maintenant des soins aux patients rentables et innovants.
En tant que leader de la m茅decine r茅g茅n茅rative depuis quatre d茅cennies, Organogenesis est un pionnier des produits cellulaires vivants bio-ing茅nieris茅s et fabrique des th茅rapies avanc茅es pour les soins des plaies, avec plusieurs plateformes technologiques soutenant des solutions cliniquement prouv茅es qui am茅liorent les r茅sultats tout en r茅duisant les co没ts globaux des soins.
Organogenesis Holdings (Nasdaq: ORGO) unterst眉tzt die Entscheidung der US-Zentren f眉r Medicare und Medicaid-Dienste (CMS), die Umsetzung der lokalen Deckungsbestimmungen (LCD) f眉r Hautersatztransplantate und zellul盲re Gewebeprodukte (CTP), die zur Behandlung von diabetischen Fu脽geschw眉ren und ven枚sen Beinulzera eingesetzt werden, zu verschieben.
Das Unternehmen bef眉rwortet den Schritt des CMS, die Deckungspolitiken zu 眉berpr眉fen, um den Patienten den Zugang zu Produkten mit hochwertigen Wirksamkeitsnachweisen, einschlie脽lich realer Evidenz, zu gew盲hrleisten. CEO Gary S. Gillheeney Sr. empfiehlt dem CMS, eine integrierte Deckungs- und Zahlungsrichtlinie umzusetzen, um die steigenden Medicare-Kosten zu adressieren und gleichzeitig eine kosteneffektive Patientenversorgung und Innovation aufrechtzuerhalten.
Als f眉hrendes Unternehmen in der regenerativen Medizin seit vier Jahrzehnten ist Organogenesis Pionier bei bioengineering lebender Zellprodukte und stellt fortschrittliche Wundversorgungstherapien her, unterst眉tzt durch mehrere Technologieplattformen, die klinisch erprobte L枚sungen bieten, die die Ergebnisse verbessern und gleichzeitig die Gesamtkosten der Versorgung senken.
- CMS delay maintains current market access for ORGO's wound care products
- Company's real-world evidence approach aligns with CMS coverage requirements
- Multiple technology platforms demonstrate clinical efficacy while reducing care costs
- Regulatory uncertainty regarding future CMS coverage policies
- Potential impact of upcoming integrated payment policy changes on revenue
- Rising Medicare costs could affect reimbursement rates
Insights
CMS's decision to delay implementation of LCDs for skin substitutes represents a significant regulatory development for Organogenesis. The delay provides a critical window for reevaluation of coverage policies for advanced wound care products used in treating diabetic foot ulcers and venous leg ulcers 鈥� two conditions with substantial Medicare population prevalence.
Organogenesis's advocacy for including "high quality evidence of effectiveness" that encompasses real-world evidence is strategically important. This approach would likely benefit established market players with extensive clinical use data rather than favoring only randomized controlled trials. For companies like Organogenesis with four decades of experience, this represents a potential competitive advantage against newer market entrants.
The company's recommendation for an "integrated coverage and payment policy" suggests they're seeking alignment between clinical evidence requirements and reimbursement structures. This indicates Organogenesis is positioning for a value-based approach where higher-quality products commanding premium prices can demonstrate overall cost-effectiveness through improved healing rates and reduced complications.
This regulatory pause creates a policy advocacy opportunity, but final CMS decisions remain uncertain. The outcome will significantly impact market access for Organogenesis's advanced wound care portfolio in the Medicare population, which represents a substantial portion of chronic wound patients.
The CMS coverage determination delay represents a near-term stabilizing factor for Organogenesis's revenue outlook. Had potentially restrictive LCDs been implemented without modification, the company might have faced reimbursement challenges for its advanced wound care products in the Medicare population 鈥� a critical demographic for chronic wound treatments.
Organogenesis's proactive engagement with CMS suggests confidence in their products' effectiveness data and a strategic approach to protecting market position. Their emphasis on real-world evidence indicates potential competitive differentiation based on accumulated clinical use data rather than solely controlled trials.
The company's advocacy for an integrated coverage and payment approach signals their focus on demonstrating economic value. Advanced wound care products typically command premium pricing but can potentially reduce total care costs through faster healing, fewer complications, and reduced hospitalizations.
For investors, this regulatory development creates a mixed picture 鈥� it maintains status quo temporarily while introducing uncertainty about future coverage decisions. Medicare reimbursement policies significantly impact Organogenesis's addressable market and revenue potential, particularly for their bioengineered living cell products and skin substitutes used in diabetic foot ulcers and venous leg ulcers.
While avoiding immediate negative impact from coverage restrictions, the extended regulatory process introduces uncertainty until final policies are determined. The company's industry leadership position and stakeholder engagement approach may provide advantages in shaping favorable outcomes.
Organogenesis recommends CMS also implement an integrated coverage and payment policy
CANTON, Mass., April 11, 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 supports the U.S. Centers for Medicare & Medicaid Services鈥� (CMS) decision to delay the local coverage determinations (LCDs) for skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) to review its coverage policies.
鈥淥rganogenesis supports an evidence-based approach to coverage and is pleased that CMS has delayed LCD implementation to review its coverage policies to ensure that patients have access to products with 鈥渉igh quality evidence of effectiveness鈥�, which we believe includes real-world evidence,鈥� said Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board of Organogenesis. 鈥淎G真人官方-world evidence not only demonstrates a product鈥檚 safety and efficacy, but also outcomes in actual clinical use.鈥�
Gillheeney continued, 鈥淎lthough we believe this is an important first step for the industry, we believe coverage policies alone are not sufficient to address rapidly escalating Medicare costs while ensuring cost-effective patient care and innovation. To that end, we recommend CMS implement an integrated coverage and payment policy. As a leader in the space, we will continue to bring stakeholders together to develop and advocate for such an integrated policy that will ensure patient access to the most appropriate products while achieving significant savings to Medicare.鈥�
Organogenesis has been a leader in regenerative medicine for four decades, innovating and manufacturing a diverse portfolio of highly effective advanced wound care therapies. The Company is a pioneer in bioengineered living cell products, creating the skin substitutes and CTP category in the chronic wound space. Organogenesis has multiple technology platforms supporting clinically proven safe and effective solutions that substantially improve outcomes while lowering the overall cost of care.
About Organogenesis Holdings Inc.聽
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 .
Investor Inquiries: ICR Healthcare Mike Piccinino, CFA [email protected] Press and Media Inquiries: Organogenesis [email protected]
FAQ
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