The LCDs Are Withdrawn - Now What?
Just before the holidays, CMS confirmed that the Local Coverage Determinations (LCDs) for skin substitutes scheduled to take effect in January 2026 have been withdrawn by the Medicare Administrative Contractors (MACs). This came shortly after CMS had introduced late-stage revisions to the LCDs, including a temporary “status quo” category intended to allow continued access to a wider range of products for an additional 12 months.
The speed and timing of these changes understandably raised questions across the wound care community. Why revise the LCDs so close to implementation - and then remove them entirely? And what does this actually mean for clinicians, manufacturers, and patients?
At this point, the precise reasoning has not been publicly clarified. It may reflect legal or procedural concerns about altering coverage policies so close to their effective date. It may also indicate a decision by CMS to restart the process more deliberately, or to consider alternative approaches such as a National Coverage Determination (NCD). Ongoing advocacy efforts across the industry may also have played a role in highlighting unintended consequences of the proposed LCDs.
What is clear is that withdrawing the LCDs does not create a simple win-lose outcome.
On one hand, without active LCDs in many jurisdictions, no specific skin substitute products are automatically excluded from coverage. This preserves clinician discretion and avoids blanket restrictions based solely on product lists rather than patient need.
On the other hand, the absence of clear coverage guidance may shift decision-making toward individual claim reviews, audits, and denials - particularly within Medicare Advantage plans, which already apply their own medical policies. In practice, this can still limit access and create administrative uncertainty for providers.
Importantly, none of this addresses the underlying reimbursement challenge. The finalized flat physician fee schedule rate of approximately $127 per square centimeter, combined with inadequate application fees in office and mobile settings, continues to put pressure on clinical decision-making. When reimbursement does not reflect the true cost and complexity of care delivery, product selection risks being driven by price rather than clinical value.
At Bobber Biotech, we believe sustainable progress requires alignment across payment, coverage, and evidence. Fair and consistent reimbursement - including parity between office-based care and hospital outpatient departments - is essential if clinicians are to choose therapies based on outcomes, not economics.
So what should the industry do now?
For clinicians, the priority remains unchanged: continue delivering evidence-based care, supported by thorough documentation and appropriate wound preparation. Advanced therapies should be used thoughtfully and in line with patient-specific needs.
For manufacturers and innovators, this moment reinforces the importance of building strong, transparent clinical evidence across wound types and care settings. The policy environment remains fluid, and assumptions about long-term stability would be premature.
And collectively, the industry must continue to support durable legislative solutions that create clarity, fairness, and accountability — protecting patient access while addressing waste and abuse through targeted oversight rather than broad restrictions.
The withdrawal of the LCDs is not the end of the conversation. It is another signal that meaningful reform will require collaboration, evidence, and a long-term view focused on patients first.