CMS announced that its 2026 Medicare Physician Fee Schedule and Outpatient Prospective Payment System rules will include Integra LifeSciences’ dermal regenerative templates, decellularized dermal scaffolds and amniotic tissue membranes—specifically Integra® matrices, PriMatrix®, Cytal® and AmnioExcel®—effective January 1 2026. The decision classifies the products as skin substitutes and assigns a uniform reimbursement rate across hospital and outpatient settings.
The inclusion removes a long‑standing reimbursement barrier that had limited adoption of Integra’s wound‑care portfolio. By standardizing payment, the company can expand access to its products, potentially increasing utilization and revenue. The move also aligns with CMS’s broader effort to streamline coverage for cellular and tissue‑based products, which is expected to benefit providers who rely on these advanced therapies.
Integra’s recent financial performance underscores the significance of the coverage expansion. In Q3 2025 the company generated $402.1 million in revenue and reported an adjusted earnings‑per‑share of $0.54, while GAAP net loss was $0.07 per diluted share. Full‑year 2025 guidance projects revenue of $1.62 billion to $1.64 billion and adjusted EPS of $2.19 to $2.24. The company estimates the U.S. implant‑based breast reconstruction and wound‑care market to be roughly $800 million, a figure that highlights the potential upside of broader Medicare coverage.
Integra’s product line competes with firms such as Acelity, Zimmer Biomet and other specialty wound‑care manufacturers. The company’s claim that it offers the widest breadth of cost‑effective, evidence‑backed skin‑substitute solutions positions it uniquely in a market where reimbursement criteria are tightening. The new CMS rule is expected to reinforce Integra’s competitive advantage by making its products more accessible to a larger payer base.
CEO Mojdeh Poul emphasized that the rule change “modernizes payment structures that prioritize innovation and improved outcomes.” The announcement signals that Integra’s strategic focus on supply‑chain resilience, quality systems and margin expansion is beginning to translate into tangible market access gains, potentially accelerating the company’s trajectory toward capturing a larger share of the wound‑care and reconstruction markets.
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