Comments to Novitas & FCSO draft LCD/LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

The Coalition submitted joint comments to Novitas and FCSO on their draft LCD for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041/DL38377) and the accompanying Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117/DA57680). The Coalition expressed concern on a range of issues within the policy, including:

• Lack of a consistent and accurate definition of a chronic non-healing ulcer
• Description of CTPs as surgical supplies
• Limitation on number of applications of CTPs in an episode that is not supported by the clinical literature
• Requirement that clinicians use “the smallest package size available for purchase"
• Conflation of the terms “Wound” and “Ulcer” throughout the policy
• Incorrect description of the application of CTPs as an adjunct therapy rather than an advanced therapy
• Restriction on switching CTP products during course of therapy

Coalition comments
Attachment A - Group 3 Codes That Should Be Included In The Group 2 Covered Product List
Attachment B - ICD-10 Codes to be added to LCA