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

Rhea-AI Summary

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.

Positive

• 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

Negative

• Regulatory uncertainty regarding future CMS coverage policies
• Potential impact of upcoming integrated payment policy changes on revenue
• Rising Medicare costs could affect reimbursement rates

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

What is the impact of CMS's LCD delay on Organogenesis (ORGO) products?

The delay allows continued coverage review of ORGO's skin substitute grafts and cellular tissue products for diabetic foot ulcers and venous leg ulcers treatment, maintaining current patient access.

How does ORGO plan to address Medicare cost challenges in 2025?

ORGO recommends implementing an integrated coverage and payment policy to manage Medicare costs while ensuring cost-effective patient care and innovation.

What types of evidence does ORGO support for CMS coverage decisions?

ORGO supports both high-quality clinical evidence and real-world evidence demonstrating product safety, efficacy, and outcomes in actual clinical use.

What are ORGO's main product offerings in the wound care market?

ORGO offers bioengineered living cell products, skin substitutes, and cellular tissue-based products for advanced wound care and surgical/sports medicine markets.