Core Viewpoint - Organogenesis supports the U.S. Centers for Medicare & Medicaid Services' (CMS) decision to delay local coverage determinations (LCDs) for skin substitute grafts and cellular and tissue-based products to review coverage policies, emphasizing the importance of high-quality evidence of effectiveness for patient access [1][2] Group 1: Company Position and Recommendations - The company advocates for an integrated coverage and payment policy to address rising Medicare costs while ensuring patient access to effective products [2] - Organogenesis has been a leader in regenerative medicine for four decades, innovating in advanced wound care therapies and bioengineered living cell products [2] - The company emphasizes the role of real-world evidence in demonstrating product safety, efficacy, and clinical outcomes [2] Group 2: Company Overview - Organogenesis Holdings Inc. focuses on the development, manufacture, and commercialization of solutions for advanced wound care and surgical and sports medicine markets [3] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3]
Organogenesis Supports CMS' Local Coverage Determination Implementation Delay to Review Coverage Policies to Maintain Patient Access with High Quality Evidence of Effectiveness