Our CEO Breaks Down the 2026 CMS Policy and What It Means for the MarketOur CEO Breaks Down the 2026 CMS Policy and What It Means for the Market
Understanding the 2026 CMS Payment Policy
On November 1st, CMS released its 2026 payment policy for skin substitutes - a document that has sparked widespread concern across wound care, orthopedics, and regenerative medicine. The policy, effective January 1, 2026, introduces a new reimbursement rate of $127.28 per square centimeter, replacing the existing ASP methodology.
In a new video, Bobber Biotech CEO Rob Odell unpacks what this change means for clinicians, manufacturers, and most importantly, patients.
A Major Shift in Reimbursement
Rob explains that this reduction - from rates that previously reached up to $5,800 per square centimeter - represents a seismic shift in the economics of wound care. It affects physician offices, outpatient centers, and mobile wound care providers across the United States.
CMS also outlined potential future structures for reimbursement based on regulatory pathways - from pre-market approvals and 510(k) clearances to 361 pathway products - hinting at a possible tiered system to reward innovation.
CMS Concerns and Market Impact
As Rob highlights, CMS repeatedly referenced the “exuberant Medicare spend” on cellular and tissue-based products, projected to exceed $15 billion by year-end - more than double last year’s figures.
While oversight is understandable, the reform may unintentionally limit patient access, especially in rural and mobile care settings, where practitioners already face higher operational costs and longer travel times. The ripple effect could include clinic closures, reduced innovation, and a widening care gap for vulnerable patient populations.
Ethical and Industry Considerations
Rob also raises an ethical concern: the potential outsourcing of raw materials to lower-cost foreign suppliers, creating risks around transparency and human tissue sourcing standards.
He further notes the financial strain on manufacturers who have invested heavily in clinical trials and data collection - efforts that appear misaligned with the final reimbursement rate. The result could be reduced venture capital and private equity investment in regenerative medicine, slowing much-needed innovation.
What Comes Next
With the government currently shut down, any progress on proposed legislation such as Senator Bill Cassidy’s Payment Reform Act remains stalled. As Rob explains, this leaves the industry in a period of uncertainty - “the calm in the eye of the hurricane.”
In the months ahead, we can expect increased audits, callbacks, and appeals, as CMS enforces stricter oversight of payment structures. Clinics and manufacturers will need to remain vigilant, compliant, and adaptive.
Continuing to Drive Innovation
Despite the challenges, Rob emphasizes Bobber Biotech’s commitment to bringing new innovations to market. Recent launches, including a hydrochloric acid wound cleanser and an expanded dressing portfolio, are designed to help clinics maintain affordability and quality care even amid reimbursement pressures.
“At Bobber Biotech,” Rob says, “we’re committed to helping providers navigate change, safeguard patient access, and continue driving innovation that changes lives permanently - and for the better.”
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