Today CMS released the final update to the Local Coverage Determinations for skin substitutes used in treating diabetic foot ulcers and venous leg ulcers. Effective January 1, 2026 — seventeen days from now — all seven Medicare Administrative Contractors will implement these changes.

If your wound center relies heavily on products that didn't make the cut, you need to act fast.

‍The Numbers

‍CMS sorted 330 product codes into three categories:

‍• 18 products are covered — they met the evidence threshold

‍• 154 products are in a 12-month "status quo" period — MACs can pay at their discretion while manufacturers complete studies

‍• 158 products are non-covered — inadequate evidence or no submission at all CMS gave manufacturers until November 1 to submit evidence. They received 66 submissions. Only 8 were actual randomized controlled trials, and of those, exactly one product — Grafix Prime — met the threshold and was added to the covered list.

‍The Double Whammy

‍This LCD update doesn't exist in isolation. The 2026 Medicare Physician Fee Schedule finalized a dramatic payment change: skin substitutes will now be reimbursed as incident-to supplies at a flat rate of approximately $127 per square centimeter, down from ASP+6% pricing that allowed some products to bill over $2,000 per square centimeter. CMS estimates this alone will reduce Medicare spending on skin substitutes by nearly 90%. Manufacturers are getting hit twice: coverage restrictions through the LCDs and a massive payment reduction through the fee schedule.

‍What This Means for Wound Centers

‍For hospital-based wound centers — especially those within larger health systems — navigating these changes requires immediate attention. Formulary decisions, documentation protocols, and compliance processes all need to align with the new requirements before January 1. The centers operating independently have flexibility to pivot quickly. Hospital networks face a different challenge: coordinating changes across multiple sites, updating EHR systems, retraining staff, and ensuring every location understands what's covered and what's not. Having the right expertise and infrastructure in place to manage these transitions isn't optional anymore — it's essential.

‍The Bottom Line

‍Lost in all the talk about reimbursement and evidence thresholds is the patient. The 18 covered products aren't there by accident — they're there because someone invested in proving they actually work. That's the standard wound care should have been held to all along. Our patients deserved better than a $10 billion experiment.

Wound Care Advantage is built for moments like this.

We guide hospitals through reimbursement shifts, tighten workflows, and make sure your wound center stays profitable and compliant. You get a steadier operation, stronger outcomes, and a partner focused on keeping these vital programs open for the patients who need them. If you’re looking for a team that knows wound care and shows up when it counts, WCA is here. We’ll help keep your program strong, efficient, and ready for what’s coming. Partner with WCA.

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About Wound Care Advantage

WCA helps wound centers run better—clinically and financially. Our platform, Luvo, delivers real-time business intelligence, compliance tools, and daily operational support, all in one place. Built for speed, clarity, and results. We give your team the expertise needed to be successful in wound care—without giving up control. Learn more at www.thewca.com.