Key Lessons from the 2025 LCD Commenting Period
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The 2025 Local Coverage Determination (LCD) for skin substitutes brought transformative updates to policies impacting diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Behind these changes lies an extensive commenting period that allowed stakeholders—ranging from healthcare providers to patient advocates and industry experts—to raise concerns, present evidence, and shape the final policy. Understanding the lessons from
this process is crucial for all affected parties, as it highlights the intricacies of policy development and its implications for care delivery.
This article examines the key lessons from the 2025 LCD commenting period, providing insights that every provider, patient, and healthcare organization should know.

1. Stakeholder Engagement Shapes Policy
Lesson Learned:
The LCD commenting period demonstrated the value of stakeholder engagement in shaping healthcare policies. Diverse voices, including medical professionals, industry representatives, and patient advocates, provided critical feedback that directly influenced the final LCD.
Key Takeaways:
The shift from “failure to respond” to “50% ulcer area reduction” as a measurable criterion was a direct response to requests for clearer, evidence-based language.
Concerns about the Ankle-Brachial Index (ABI) being too restrictive led to its replacement with the broader term “vascular assessment,” making the policy more inclusive for patients with limited access to specific diagnostic tools.
Why It Matters:
These changes highlight the importance of provider and patient advocacy in ensuring policies remain practical and effective. Engaging in public comment periods allows stakeholders to address gaps and advocate for realistic standards that support care delivery.
2. Evidence-Based Policy Development
Lesson Learned:
The emphasis on peer-reviewed literature and real-world evidence (RWE) underscores Medicare’s commitment to evidence-based decision-making. However, the process also revealed gaps in the current body of research.
Key Takeaways:
Products like Epifix were added to the DFU coverage list due to new evidence submitted during the commenting period.
Systematic reviews and real-world evidence were added to the policy to provide greater context, but limitations in study design and sample size were noted.
Practical Implications:
Providers should be proactive in contributing to high-quality research, as robust evidence is pivotal for product inclusion and coverage decisions. Medical organizations and manufacturers should prioritize generating and publishing data to meet Medicare’s standards.
3. Documentation and Compliance Are Critical
Lesson Learned:
Concerns about proper documentation and compliance emerged as recurring themes. Medicare’s focus on transparency and accountability places greater responsibility on providers to maintain precise records.
Key Takeaways:
Wastage documentation requirements were clarified, emphasizing the need to document unused portions of skin substitute grafts with accurate measurements.
The introduction of the KX modifier for extended applications (beyond four per treatment episode) requires providers to document medical necessity with detailed evidence, including pre-and post-treatment wound assessments.
Why It Matters:
These updates highlight the importance of robust administrative practices. Providers must ensure their teams are trained to meet documentation standards to avoid claim denials and ensure uninterrupted patient care.
4. Flexibility in Clinical Practice
Lesson Learned:
The final LCD reflects a shift toward greater flexibility in clinical practice, addressing concerns raised about restrictive policies in the proposed version.
Key Takeaways:
Expanding the treatment duration from 12 to 16 weeks provides clinicians with more time to achieve meaningful wound healing outcomes.
Removing “uncontrolled diabetes” from contraindications acknowledges the complexity of managing chronic conditions, ensuring that patients with comorbidities are not unfairly excluded.
Impact on Providers and Patients:
These changes empower providers to tailor treatment plans to individual patient needs while reducing barriers to access for high-risk populations.
5. Importance of Clarified Language and Definitions
Lesson Learned:
Ambiguity in policy language can lead to confusion and misinterpretation. Many commenters requested clearer definitions and language to ensure consistency in application.
Key Takeaways:
Clarifications were added regarding the use of skin substitute grafts on wounds with exposed muscle, tendon, or bone.
Additional definitions and examples were included in the Billing and Coding (B&C) article to improve understanding of terms like “wastage” and “medical necessity.”
Practical Implications:
Healthcare practices must stay updated on these clarifications to ensure compliance. Providers should review the B&C article regularly to align their documentation and billing processes with the latest standards.
6. Challenges and Opportunities in Coverage Decisions
Lesson Learned:
The 2025 LCD highlights the challenges of balancing access to innovative treatments with the need for evidence-based coverage. Many stakeholders raised concerns about the exclusion of certain products due to insufficient evidence.
Key Takeaways:
Products like Oasis Tri-Layer Wound were removed from coverage due to a lack of robust supporting evidence.
Providers and manufacturers must navigate the evolving landscape of coverage requirements by staying informed and contributing to ongoing policy discussions.
Why It Matters:
This dynamic underscores the need for collaboration among providers, manufacturers, and policymakers to ensure that coverage decisions reflect both scientific rigor and real-world clinical needs.
Frequently Asked Questions
What is the significance of the "50% ulcer area reduction" criterion?
The “50% ulcer area reduction” criterion replaces the ambiguous term “failure to respond,” providing a clear, measurable benchmark for evaluating treatment efficacy.
How do the updates to the KX modifier impact providers?
The KX modifier is now required for claims involving more than four applications of skin substitutes within a treatment episode. Providers must document the medical necessity of additional applications.
Why was the Ankle-Brachial Index replaced with vascular assessment?
Commenters noted that requiring ABI could limit access to care for patients without access to specialized equipment. The term “vascular assessment” broadens the scope and allows for alternative diagnostic methods.
What are the implications of the expanded treatment duration to 16 weeks?
The extended treatment duration provides clinicians with more flexibility to achieve meaningful wound healing, accommodating patients with slower healing trajectories.
How can providers stay updated on future LCD changes?
Providers should monitor CMS announcements, subscribe to relevant updates, and participate in public comment periods to stay informed and contribute to policy development.
How WoundGenex Can Help
Navigating the complexities of the 2025 LCD and its updates can be overwhelming. WoundGenex is here to simplify the process and provide comprehensive support to healthcare practices:
Policy Training: Equip your team with the knowledge needed to implement changes seamlessly.
Documentation Review: Ensure your records meet the latest compliance standards, including wastage documentation and use of modifiers.
Billing and Coding Assistance: Optimize your claims process to avoid denials and delays.
Ongoing Support: Stay ahead of future policy updates with expert guidance and resources tailored to your needs.