Written by
Dr. Windy Cole, DPM, CWSP
January 2025
Recent updates to Local Coverage Determination (LCD) guidelines for cellular tissue products (CTPs), effective April 2025, introduce stricter compliance requirements with significant implications for providers treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). These changes aim to improve patient outcomes, ensure regulatory adherence, and promote efficient resource use.
In our recent webinar, “CAMPs and Compliance: Essential LCD Updates, Documentation Best Practices, and Audit Readiness”, experts Eric Lullove, Martha Kelso, and Christopher Bromley shared insights into these updates and how providers can align with the new standards.
Below we’ve summarized the key documentation requirements for the use of CTPs in wound care, what this could mean for manufacturers and distributors, and how eKare can help.
Key Changes in the Updated LCD Guidelines
1. Enhanced Measurement Requirements
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- Weekly Documentation: Providers must record wound size, depth, and surface area at every stage of treatment, from initial assessments to follow-ups and CTP applications.
- Pre- and Post-Debridement Measurements: Adding these ensures accurate and comprehensive documentation of the wound’s condition.
2. Improved Documentation Standards
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- Detailed Patient Records: Chronicity of the wound, patient compliance, and systemic treatments must be clearly documented, alongside failed responses to standard of care (SOC).
- Specific Justifications: Providers need to explain why CTPs are medically necessary, include the number of anticipated applications, and document positive wound responses for reapplications (e.g., granulation tissue growth, reduced size or exudate, and decreased pain).
- Pause for Non-Response: If the wound shows no improvement, future applications should be withheld until underlying issues are identified and addressed.
3. Attestation for Additional Applications
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- For applications exceeding four (up to a maximum of eight), providers must submit formal attestations demonstrating medical necessity and adherence to the guidelines.
4. Focus on Wastage Reduction
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- Product Sizing: Align CTP sizing with wound dimensions to minimize wastage.
- Waste Documentation: Providers must record the product units used, the amount wasted, and reasons for any excess, ensuring cost efficiency.
What This Means for CTP Manufacturers and Distributors
- Increased Documentation Demands: Accurate, real-time data management tools are essential for tracking wound progress and compliance.
- Regulatory Risks: Non-compliance can lead to reimbursement denials, hindering product adoption and profitability.
- Opportunities for Growth: Companies with compliance-friendly, evidence-backed products can gain a competitive advantage in the marketplace.
How eKare inSight Can Help
eKare inSight is a powerful digital platform designed to help CTP manufacturers and distributors align with the updated LCD guidelines:
- Accurate Wound Measurement: Automatically calculate wound size, depth, and surface area with precision to meet compliance requirements.
- Photo Documentation: Capture high-resolution images with metadata (e.g., date, patient ID) for audit-ready records.
- Longitudinal Tracking: Generate detailed reports showing wound healing trajectories to justify continued use or additional applications of CTPs.
- Waste Management: Optimize product sizing and reduce wastage with preloaded CTP dimensions and precise wound area calculations.
- Audit-Ready Storage: Securely store all documentation for quick retrieval during audits or claim reviews, ensuring HIPAA compliance.
The updated LCD guidelines bring both challenges and opportunities for CTP manufacturers and distributors. By adopting eKare inSight, organizations can simplify compliance, demonstrate measurable outcomes, and position their products for greater success in a competitive market.
📅 Contact us today to learn how eKare inSight can support your compliance and growth goals!
About the author
Dr. Windy Cole, DPM
Director of Wound Care Research·Kent State University College of Podiatric Medicine
The views and opinions expressed here are those of the author and do not necessarily reflect official policy or position of any other agency, organization, employer or company.
Dr. Windy Cole, DPM, has practiced in Northeast Ohio for over 22 years. She is an adjunct professor and Director of Wound Care Research at Kent State University College of Podiatric Medicine. She is board certified by the American Board of Foot and Ankle Surgery and the American Board of Wound Management. She has been a dedicated wound care advocate for two decades with interests in medical education, diabetic foot care, wound care, limb salvage and clinical research. Dr. Cole has published many peer-reviewed and industry articles on these topics and is a sought-after speaker both nationally and internationally. She is a feature writer for Podiatry Management and Today’s Wound Clinic as well as a contributing writer for Podiatry Today. She is an Editorial Board member of Wound Management and Prevention, Podiatry Today, The Foot Journal, Wound Masterclass, Podiatry Management and Lower Extremity Review. She is also the Podiatry Section Editor for the ePlasty Journal and a Guest Editor for Foot and Ankle Quarterly. She is a wound care advocate on the forefront of wound research and was the 2020 World Union of Wound Healing Silver Medal Award recipient for her work in Technology-driven Research and the 2022 recipient of the Kaplan-Kanat Memorial Lecture Award.