Organogenesis Supports CMS’ 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 qualità, 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 è 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 decisión de los Centros de Servicios de Medicare y Medicaid de EE. UU. (CMS) de retrasar la implementación 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 úlceras del pie diabético y úlceras venosas en las piernas.
La compañía respalda el movimiento del CMS para revisar las políticas 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 política de cobertura y pago integrada para abordar el aumento de los costos de Medicare, manteniendo al mismo tiempo una atención al paciente rentable e innovadora.
Como líder durante cuatro décadas en medicina regenerativa, Organogenesis es pionera en productos celulares vivos bioingenierizados y fabrica terapias avanzadas para el cuidado de heridas, con múltiples plataformas tecnológicas que respaldan soluciones clínicamente probadas que mejoran los resultados mientras reducen los costos generales de atención.
Organogenesis Holdings (Nasdaq: ORGO)는 미국 메디케어 및 메디케이드 서비스 센터(CMS)의 결정을 지지하여 당뇨병성 발 궤양 및 정맥성 하지 궤양 치료에 사용되는 피부 대체 이식편 및 세포 조직 기반 제품(CTP)의 지역 커버리지 결정(LCD) 시행을 연기합니다.
회사는 환자가 고품질 효과 증거, 실제 세계 증거를 포함한 제품에 접근할 수 있도록 보장하기 위해 CMS의 정책 검토를 지지합니다. CEO Gary S. Gillheeney Sr.는 CMS가 메디케어 비용 상승에 대응하기 위해 통합된 커버리지 및 지불 정책을 시행할 것을 권장하며, 비용 효율적인 환자 치료와 혁신을 유지합니다.
40년 동안 재생 의학 분야의 선두주자로서 Organogenesis는 생체 공학적 살아있는 세포 제품을 개척하고, 임상적으로 입증된 솔루션을 지원하는 여러 기술 플랫폼을 통해 상처 치료 요법을 제조하여 결과를 개선하고 전체 치료 비용을 줄이고 있습니다.
Organogenesis Holdings (Nasdaq: ORGO) soutient la décision des Centres américains pour Medicare et Medicaid (CMS) de retarder la mise en œuvre des déterminations de couverture locales (LCD) pour les greffes de substituts cutanés et les produits à base de tissus cellulaires (CTP) utilisés dans le traitement des ulcères du pied diabétique et des ulcères veineux des jambes.
L'entreprise approuve la démarche du CMS visant à revoir les politiques de couverture afin d'assurer l'accès des patients à des produits disposant de preuves d'efficacité de haute qualité, y compris des données du monde réel. Le PDG Gary S. Gillheeney Sr. recommande au CMS de mettre en œuvre une politique intégrée de couverture et de paiement pour faire face à l'augmentation des coûts de Medicare tout en maintenant des soins aux patients rentables et innovants.
En tant que leader de la médecine régénérative depuis quatre décennies, Organogenesis est un pionnier des produits cellulaires vivants bio-ingénierisés et fabrique des thérapies avancées pour les soins des plaies, avec plusieurs plateformes technologiques soutenant des solutions cliniquement prouvées qui améliorent les résultats tout en réduisant les coûts globaux des soins.
Organogenesis Holdings (Nasdaq: ORGO) unterstützt die Entscheidung der US-Zentren für Medicare und Medicaid-Dienste (CMS), die Umsetzung der lokalen Deckungsbestimmungen (LCD) für Hautersatztransplantate und zelluläre Gewebeprodukte (CTP), die zur Behandlung von diabetischen Fußgeschwüren und venösen Beinulzera eingesetzt werden, zu verschieben.
Das Unternehmen befürwortet den Schritt des CMS, die Deckungspolitiken zu überprüfen, um den Patienten den Zugang zu Produkten mit hochwertigen Wirksamkeitsnachweisen, einschließlich realer Evidenz, zu gewährleisten. 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 führendes Unternehmen in der regenerativen Medizin seit vier Jahrzehnten ist Organogenesis Pionier bei bioengineering lebender Zellprodukte und stellt fortschrittliche Wundversorgungstherapien her, unterstützt durch mehrere Technologieplattformen, die klinisch erprobte Lösungen 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 – 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 – 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 – 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’ (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.
“Organogenesis 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 “high quality evidence of effectiveness”, which we believe includes real-world evidence,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board of Organogenesis. “Real-world evidence not only demonstrates a product’s safety and efficacy, but also outcomes in actual clinical use.”
Gillheeney continued, “Although 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.”
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.
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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