Organogenesis Applauds CMS Proposal to Reform Skin Substitute Payment Policy; Urges Refinements to Ensure Patient Access to Appropriate Products and Continued Innovation

Rhea-AI Summary

Organogenesis (Nasdaq: ORGO), a regenerative medicine company, has expressed support for the Centers for Medicare & Medicaid Services' (CMS) proposed new payment methodology for skin substitutes in CY 2026. The proposal introduces a per centimeter square payment system based on FDA classification across both physician office and hospital outpatient settings.

CEO Gary S. Gillheeney highlighted that the new structure aims to reduce system abuse and Medicare spending while ensuring consistent payment across care sites. The proposal notably recognizes PMA products' clinical differentiation and seeks to expand access to innovative wound healing technologies that help reduce amputations and complications.

Positive

• None.

Negative

• Current system facing issues with abuse and rapid Medicare spending escalation
• Payment structure requires further refinement to ensure long-term stability

CANTON, Mass., July 15, 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, applauds the Centers for Medicare & Medicaid Services’ (CMS) proposed new payment approach for skin substitutes/cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule and urges CMS to establish 2026 payment rates based on clinical value and relative cost.

“We are pleased CMS is proposing a per centimeter square payment methodology based on FDA classification for skin substitutes in both the physician office and hospital outpatient department settings,” said Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis. “We believe this new payment structure will curb abuse under the current system, and the resulting rapid escalation in Medicare spending, while ensuring a much-needed consistent payment approach across sites of care. We are also pleased CMS has recognized the clinical differentiation of PMA products and has taken steps to expand access to these innovative wound healing technologies to ensure patients receive the most appropriate therapy, which have been proven to reduce life-threatening amputations and complications.”

Mr. Gillheeney continued, “With more than forty years of leadership in regenerative medicine, and a diverse portfolio with technologies in each FDA category, we believe we are well-positioned for future growth in an evolving wound care market. We remain committed to working with CMS and other stakeholders to further refine the proposed policies to promote long-term stability and continue to expand access to PMA products that patients need and deserve, all while reducing the overall cost to Medicare.”

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.  

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “will,” “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to CMS’ new payment structure and the likelihood that it will curb abuse, slow the rapid escalation in Medicare spending and ensure a consistent payment approach across sites of care, as well as expectations regarding separate 2026 payment rates based on clinical value and relative cost, all of which could benefit the Company. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to the risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

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 changes did CMS propose for skin substitute payments affecting Organogenesis (ORGO) in 2026?

CMS proposed a per centimeter square payment methodology based on FDA classification for skin substitutes in both physician office and hospital outpatient department settings.

How will the new CMS payment policy affect Organogenesis (ORGO) operations?

The company is well-positioned with a diverse portfolio across FDA categories and expects the new structure to provide consistent payments across care sites while reducing system abuse.

What are the benefits of the new CMS payment structure for wound care products?

The structure aims to curb system abuse, reduce Medicare spending, ensure consistent payments across care sites, and expand access to innovative wound healing technologies that help reduce amputations.

How is Organogenesis (ORGO) positioned in the wound care market?

With over 40 years of leadership in regenerative medicine and a diverse portfolio across FDA categories, the company is well-positioned for future growth in the evolving wound care market.

What improvements does Organogenesis (ORGO) want in the CMS proposal?

The company urges CMS to establish 2026 payment rates based on clinical value and relative cost, and seeks refinements to promote long-term stability and expanded access to PMA products.