Updated December 24: The planned January 1, 2026 LCD crack-down on skin substitutes has been pulled back. As per this Fact Sheet: "CMS’ A/B Medicare Administrative Contractors (MACs) are withdrawing the Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers that were scheduled to become effective on January 1, 2026."
An OIG investigation found millions in erroneous payments. Medicare slashed reimbursement to roughly $100, a dramatic Coverage Determination was drafted limiting payments and introduced far reaching requirements.
The wound care world changed overnight. Companies vanished. Fingers were pointed. The wound care industry entered a tumultuous period that many thought would end it entirely.
Sound Familiar? You may be surprised to know that I am not referencing today, this was actually 25 years ago in 2000!
The OIG investigation into hyperbaric oxygen therapy, Hyperbaric Oxygen Therapy: Its Use and Appropriateness, which had come out in 2019, found millions in erroneous payments for inappropriate or excessive treatments, inadequate physician attendance, and insufficient documentation. What followed was swift and brutal: HCFA (now CMS) slashed reimbursement from $550 per treatment to roughly $100. They published the first National Coverage Determination limiting payment to specific indications and introduced documentation requirements that fundamentally changed how we operated.
Here's the thing: after the fallout, something remarkable happened. CMS approved new indications for HBO in 2002. Reimbursement standardized. Electronic documentation emerged. Outpatient centers exploded. Amputations reduced and healing rates improved. Our industry entered the "Golden Age" of wound care—all on the heels of what felt like an extinction event.
I'm watching history repeat itself.
The skin substitute and mobile wound care industry is facing the same pattern. Medicare spending ballooned from $256 million in 2019 to over $10 billion by 2024. (I believe it will more than double again for 2025 with my money on a total spend of just under $30 billion) Now we're seeing slashed reimbursement, specific Coverage Determinations, and demands for evidence.
The playbook hasn't changed.
When a single product application costs twenty times what an entire course of outpatient treatment historically cost—is anyone surprised? This playbook will be used again when PRP, electronic dressings, or nitric oxide grow beyond sustainable bounds.
But here's what I know from living through this: mobile wound care and skin substitutes existed before this explosion, and they'll thrive after. The companies that survive will navigate the new reimbursement environment, meet documentation requirements, and weather the audits coming. Stability and clarity build longevity.
What happens next is what matters. What comes next can be better than what came before—if as an industry, we are willing to adapt and move forward.
