Organogenesis Applauds CMS’s Significant Step In Payment Reform

Rhea-AI Summary

Organogenesis (Nasdaq: ORGO) applauded CMS’s finalization of payment reform for skin substitutes/CTPs under the CY 2026 Physician Fee Schedule announced Nov. 3, 2025.

The company highlighted that CMS finalized FDA classifications and a per centimeter-square payment methodology for both physician office and hospital outpatient settings, and said CMS recognized the clinical differentiation of PMA products, which the company believes will increase access and support higher payment and expanded access for PMA technologies. Organogenesis reiterated its multi-decade leadership and said its evidence-based portfolio positions it well for the skin substitutes market in 2026 and beyond.

The release contains forward-looking statements and cautions that actual outcomes are subject to risks and uncertainties described in the company’s SEC filings.

Positive

• CMS finalized per centimeter-square payment methodology for CY 2026
• CMS recognized PMA clinical differentiation, enabling potential higher payment
• Organogenesis states it has a diverse evidence-based portfolio across FDA categories

Negative

• Outcomes remain forward-looking and subject to risks cited in the company’s 2024 10-K
• No quantified financial impact or guidance provided for CY 2026 policy changes

With evidence-based portfolio including technologies in each FDA category, we believe we are best positioned in the skin substitutes market for 2026 and beyond

CANTON, Mass., Nov. 03, 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) significant step in payment reform for skin substitutes/cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule.

“We congratulate CMS on taking this significant step in payment reform and are pleased CMS finalized FDA classifications and a per centimeter square payment methodology in both the physician office and hospital outpatient settings,” said Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis. “We believe this new policy will increase access to PMA products while addressing abuse under the current system.”

Mr. Gillheeney continued, “We are also pleased that CMS has recognized the clinical differentiation of PMA products and taken steps toward higher payment and expanded access for PMA products. We remain committed to working with CMS and other stakeholders to further expand access to these life-saving technologies as well as incentivize investment and innovation in the space and achieve long-term market stability.”

“With more than forty years of leadership in regenerative medicine, and a diverse evidenced-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitutes market for 2026 and beyond,” concluded Mr. Gillheeney.

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’s new payment structure and the likelihood that it will increase access to PMA products and address abuse under the current system. Forward-looking statements with respect to the operations of the Company, future growth, strategies, prospects, and other aspects of the business of the Company, including the Company’s positioning in the skin substitutes market for 2026 and beyond, 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.

Investor Inquiries:
ICR Healthcare
Mike Piccinino, CFA
OrganoIR@icrinc.com

Press and Media Inquiries:
Organogenesis
communications@organo.com 

FAQ

What did Organogenesis announce about CMS payment reform on Nov 3, 2025 for ORGO?

Organogenesis said CMS finalized FDA classifications and a per centimeter-square payment methodology for skin substitutes under the CY 2026 Physician Fee Schedule.

How does the CY 2026 payment change affect PMA products according to ORGO?

The company said CMS recognized PMA clinical differentiation, which it believes supports higher payment and expanded access for PMA products.

Does Organogenesis provide financial guidance tied to the CMS CY 2026 policy change?

No; the release contains no quantified financial guidance or projected revenue impact tied to the policy change.

Why does Organogenesis say it is well positioned for the skin substitutes market in 2026 (ORGO)?

Organogenesis cited >40 years of leadership and a diverse evidence-based portfolio with technologies in each FDA category as positioning for 2026.

What caution does Organogenesis include about the CMS announcement (ORGO)?

The company noted these are forward-looking statements and actual results may differ due to risks described in its Form 10-K for year ended Dec 31, 2024.