- Organogenesis (ORGO, Financial) supports CMS's decision to delay local coverage determinations (LCDs) for skin substitute products.
- The delay allows continued review to ensure products have high-quality evidence of effectiveness, including real-world evidence.
- Organogenesis advocates for an integrated coverage and payment policy to manage Medicare costs effectively.
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leader in regenerative medicine, has expressed support for the U.S. Centers for Medicare & Medicaid Services' (CMS) decision to postpone 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 delay is intended to allow a thorough review of coverage policies to ensure patient access to products backed by high-quality effectiveness evidence, including real-world data.
Gary S. Gillheeney Sr., President and CEO of Organogenesis, emphasized the significance of real-world evidence, stating that it not only demonstrates a product's safety and efficacy but also its performance in clinical settings. He highlighted the need for coverage policies that support both innovation and cost-effective patient care amidst escalating Medicare costs.
Organogenesis has recommended that CMS implement an integrated coverage and payment policy. This strategic alignment aims to enhance patient access to appropriate products while achieving substantial savings for Medicare. As a pioneer in bioengineered living cell products, Organogenesis remains committed to advancing wound care therapies and advocating for policies that promote high-quality care solutions.
With four decades of experience in regenerative medicine, Organogenesis continues to innovate and manufacture effective advanced wound care products, supported by multiple technology platforms that have demonstrated clinical efficacy and a reduction in overall care costs.
