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Organogenesis Applauds Withdrawal of Local Coverage Determinations by Novitas, First Coast Service Options and CGS

Key Takeaway: Organogenesis Holdings Inc. praised the withdrawal of local coverage determinations (LCDs) by three Medicare Administrative Contractors for Skin Substitute Grafts intended for treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. This decision, effective October 1, aims to prevent negative health outcomes including prolonged treatment and amputations. CEO Gary S. Gillheeney emphasized the importance of this outcome for patient care and the support from various stakeholders in challenging the LCDs.
Price reaction · baseline $2.65 (2023-09-27 close) · hit after-hours · clean, no other ORGO news in the window
day 0 close · peak
+27.9%
day 1
+20%
day 3
+10.9%

Market Sentiment Analysis

POSITIVE FACTORS

  • Withdrawal of LCDs is seen as a win for patient care.
  • The decision is likely to prevent negative health outcomes like amputations.
  • Stakeholder support was crucial in achieving this outcome.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~4 mo
High dilution risk
Lead asset
Amniotic Allograft
Phase 3 · Knee Osteoarthritis

Full Press Release Details

CANTON, Mass., Sept. 28, 2023 (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, applauds today’s decision by the three Medicare Administrative Contractors (MACs) to withdraw the final local coverage determinations (LCDs) for Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers (DFU) and Venous Leg Ulcers (VLU) scheduled to take effect on October 1.
“We applaud the MACs and the Centers for Medicare & Medicaid Services (CMS) for carefully considering stakeholder concerns regarding the LCDs’ potential negative impact and putting the needs of patients first in coming to this decision,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board of Organogenesis. “Their action will make a difference in the lives of thousands of patients.”
“We thank all stakeholders, including physicians, patient advocacy groups, and clinical and industry associations, concerned about negative health outcomes, including prolonged treatment and serious infections which often lead to amputations and associated higher rates of mortality for their support challenging the LCDs. We also thank stakeholders concerned about the treatment disparity and health inequity impact the LCDs would have had on populations with higher rates of diabetes and comorbidities for their support,” Gillheeney concluded.
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.

Frequently Asked Questions

What decision did Medicare Administrative Contractors make?

The MACs decided to withdraw the final local coverage determinations for Skin Substitute Grafts.

When were the LCDs for Skin Substitute Grafts scheduled to take effect?

The LCDs were set to take effect on October 1.

Who expressed gratitude for the MACs' decision?

Gary S. Gillheeney, President and CEO of Organogenesis, expressed gratitude.

Why were stakeholders concerned about the original LCDs?

Stakeholders worried about negative health outcomes and treatment disparities.

What does Organogenesis Holdings focus on?

Organogenesis focuses on regenerative medicine for advanced wound care and surgery.

Last updated: Sep 28, 2023