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ORGO Positive Sentiment Score: 75/100

Organogenesis Supports CMS’ Local Coverage Determination Implementation Delay to Review Coverage Policies to Maintain Patient Access with High Quality Evidence of Effectiveness

Key Takeaway: Organogenesis Holdings Inc. has expressed support for the U.S. Centers for Medicare & Medicaid Services' decision to delay its local coverage determinations for skin substitute grafts aimed at treating diabetic foot ulcers and venous leg ulcers. The company emphasizes the importance of maintaining patient access to high-quality evidence-based products. While acknowledging this as a positive first step, Organogenesis advocates for an integrated coverage and payment policy to address the growing Medicare costs while ensuring effective patient care and innovation. The company's leadership in regenerative medicine over four decades further establishes its influence in the field.

Market Sentiment Analysis

POSITIVE FACTORS

  • Support for CMS's delay indicates a commitment to evidence-based coverage.
  • Opportunity to maintain patient access to high-quality products.
  • Organogenesis is recognized as a leader in regenerative medicine.
  • Encouragement for integrating coverage and payment policies could drive innovation.

CONCERNS & RISKS

  • Potential delays in coverage implementation may prolong uncertainty for patients.
  • Rapidly escalating Medicare costs remain a concern despite delayed implementation.

Full Press Release Details

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.

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Frequently Asked Questions

What is the focus of Organogenesis Holdings Inc.?

Organogenesis is focused on developing, manufacturing, and commercializing solutions for advanced wound care and surgical and sports medicine.

Why did CMS delay the coverage determinations for skin substitutes?

CMS delayed the coverage determinations to review policies ensuring patient access to products backed by high-quality evidence of effectiveness.

What does Organogenesis believe is necessary beyond coverage policies?

Organogenesis believes an integrated coverage and payment policy is critical to manage Medicare costs and ensure effective patient care.

How long has Organogenesis been a leader in regenerative medicine?

Organogenesis has been a leader in regenerative medicine for four decades, innovating effective advanced wound care therapies.

What types of products does Organogenesis offer?

Organogenesis offers a diverse portfolio of advanced wound care therapies and bioengineered living cell products.

Last updated: Apr 11, 2025