April 29, 2022
Oral Comments on Novitas Draft LCD "Skin Substitutes for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers"
For the purposes of this public meeting, the Alliance focused on four primary concerns:
1) Many of the statements and limitations in the policy do not have the scientific evidence to support them. Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. 2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. 3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. 4)The Alliance flagged significant procedural issues with the release of this draft LCD - as Novitas did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD. The Alliance's perspective will be expanded in submitted written comments.
