Integra LifeSciences Welcomes Policy Advancements Supporting Medicare Beneficiary Access

Rhea-AI Summary

Integra LifeSciences (Nasdaq: IART) welcomed the Centers for Medicare & Medicaid Services CY 2026 Medicare Physician Fee Schedule and OPPS rules that include all Integra skin substitutes. The ruling covers Integra matrices, PriMatrix, Cytal and AmnioExcel across four distinct technology platforms and establishes a uniform reimbursement rate across care settings.

The company said the change positively affects multiple regulatory pathways, including its FDA‑approved PMA Integra Dermal Regeneration Template, and enables expansion of commercial presence beyond hospitals to increase patient access to wound reconstruction products.

Positive

• CMS included all Integra skin substitutes in CY 2026 rules
• Uniform reimbursement rate across care settings
• Four technology platforms (Integra matrices, PriMatrix, Cytal, AmnioExcel)
• Regulatory pathways positively impacted, including FDA‑approved PMA product

Negative

• None.

Insights

Health Policy & Reimbursement Analyst

CMS's CY 2026 uniform reimbursement for skin substitutes expands access and likely improves Integra's revenue mix across care settings.

Integra benefits because the rule explicitly includes its skin substitutes—Integra® matrices, PriMatrix®, Cytal®, and AmnioExcel®—creating a single reimbursement pathway across care settings for Calendar Year 2026. A uniform payment rate simplifies billing, reduces site-of-care payment gaps, and can make outpatient or ambulatory settings economically viable for procedures that previously concentrated in hospitals.

The policy's positive effect depends on adoption, coding implementation, and commercial rollout; operational execution and payer edits could slow realization. Monitor CMS implementation guidance, CPT/HCPCS coding clarifications, and early utilization trends over the next 6–12 months to gauge uptake and revenue impact.

Company to advance care through broader access to breadth of skin substitutes across four unique technology platforms

PRINCETON, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, commends the Centers for Medicare & Medicaid Services (CMS) on its Calendar Year 2026 Medicare Physician Fee Schedule and Outpatient Prospective Payment System rules. All Integra dermal regenerative templates, decellularized dermal scaffolds and amniotic tissue membranes, which are classified as skin substitutes by CMS, are included in the ruling. These products – Integra^® matrices, PriMatrix^®, Cytal^® and AmnioExcel^® – utilize four different technology platforms for a wide range of complex cases in wound reconstruction. Integra’s diverse portfolio spans multiple regulatory pathways positively impacted by these rulings—including the FDA-approved (PMA), world-renowned flagship Integra^® Dermal Regeneration Template.

“We applaud CMS for taking this unprecedented step to meaningfully modernize payment structures that prioritize both innovation and improved outcomes,” said Mojdeh Poul, president and chief executive officer, Integra LifeSciences. “The uniform reimbursement rate across care settings enables us to expand access to our diverse portfolio of products. No other company offers this breadth of cost-effective wound reconstruction solutions backed by science, supported by clinical evidence, and aligned to the reimbursement changes.”

“This is a pivotal advancement for our industry and the patients we serve,” said Robert T. Davis, Jr., executive vice president and president of Integra’s Tissue Technologies division. “With a robust commercial footprint already established in the hospital setting, we are poised to make a lasting impact as the procedural landscape evolves. We are also expanding our commercial presence across the continuum of care to benefit as many patients as possible. We believe the new policy will reward innovation, quality, and patient outcomes – areas where Integra has consistently led.”

About Integra

Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, the commercial impact of the reimbursement rate decisions described herein as well as the availability, market potential, and therapeutic applications and efficacy of the Integra products described herein. There can be no assurance that the reimbursement rate decisions described herein will affect or alter the commercial performance or success of any Integra product. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Integra’s business which include but are not limited to: the Company’s ability to predict accurately the demand for products and to develop strategies to successfully address relevant markets; physicians’ willingness to adopt and third-party payers’ willingness to provide reimbursement for the Company’s products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; global macroeconomic and political conditions; and the economic, competitive, governmental, technological and other risk factors and uncertainties identified under the headings “Risk Factors” and “Special Note Regarding Forward-Looking Statements,” included in Integra's Annual Report on Form 10-K for the year ended December 31, 2024, and information contained in subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and Integra undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Relations Contact:
Chris Ward
(609) 772-7736
chris.ward@integralife.com

Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a6593ae3-6b6d-467d-8cf8-1a5cd716d290

FAQ

What did CMS rule for Integra (IART) in the CY 2026 Medicare payment rules?

CMS included all Integra skin substitutes in the CY 2026 Physician Fee Schedule and OPPS rules, applying a uniform reimbursement rate across care settings.

Which Integra products (IART) are covered by the CY 2026 Medicare ruling?

The ruling covers Integra matrices, PriMatrix, Cytal and AmnioExcel, classified as skin substitutes by CMS.

How does the CY 2026 CMS change affect Integra (IART) commercial access?

Integra said the uniform reimbursement rate enables expansion of commercial presence beyond hospitals to increase patient access.

Does the CMS decision affect Integra’s FDA‑approved products (IART)?

Yes; the company said multiple regulatory pathways are positively impacted, including its FDA‑approved PMA Integra Dermal Regeneration Template.

When did Integra (IART) announce its response to the CMS CY 2026 rules?

Integra announced its response on November 25, 2025.