On April 13, 2025, new changes will go into effect with respect to a local coverage determination (LCD) issued by the Centers for Medicare and Medicaid Services.¹ This LCD outlines updates in how and under what circumstances one can apply skin substitutes/cellular and tissue-based products (CTPs). 

Some key highlights of this LCD include¹:    
•    Before using a skin substitute/CTP, the patient must receive at least 4 weeks of standard wound treatment.    
•    Standard of care treatment is now more clearly defined in this LCD. 

• For diabetic foot ulcers (DFUs), there must be documented failure to achieve 50% improvement in wound dimensions over that 4 week period, along with evidence of offloading intervention and proper local wound care.   
• For venous leg ulcers (VLUs), consistent appropriate use of compression therapy must be in place and documented, along with measurable wound healing progress.

•    There is now a limit of a maximum of 8 applications over a 16-week span of time.     
•    If a provider wishes to use more than 4 applications, however, they must be able to show evidence of progression towards healing.     
•    Any use instance above 4 applications requires the use of a KX modifier. Reporting this modifier signifies acknowledgement of and compliance with, the terms within the LCD and the continued medical necessity of the application.    
•    The KX modifier is not a substitute for compliant documentation, which is still required for all applications.    
•    When applying a skin substitute/CTP, there must be documentation of the size of the product used, and the size of any wastage. The provider must use the smallest appropriate product size to minimize such wastage.    
•    The LCD spells out specific products with coverage for treating DFUs and/or VLUs, and which products they have deemed non-covered at present due to insufficient efficacy evidence.

The above points are only select features of the changes, and providers and organizations should consult their specific LCD to learn more about specifics and details to implement into their workflows. At the time of this publication, these changes have yet to go into effect, and as such, it will be important to remain on the pulse of the regulations and how they will impact the wound care community and patients.

Reference:    
1. Centers for Medicare and Medicaid Services. Skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers. L35401. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=3504…; . Published November 14, 2024. Accessed January 15, 2025.

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