Comments to Novitas and FCSO Draft LCD on Skin Substitutes for DFU/VLU

The Coalition submitted comments to Novitas and First Coast Service Option expressing its major concerns with the proposed LCD (DL35041/DL36377) and LCA (DA54117/DA57680) on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The comments follow initial submission of detailed feedback in May 2022 and oral testimony at MACs' August public meeting. The Coalition again raised the following objections in its submitted comments:

• The policies are not in the best interest of patients.
• The policies are not supported by clinical evidence or guidelines. Evidence has been omitted from the policy review. What has been utilized is either not the most currently available, or is used in such a way that is contradictory to the points Novitas/FCSO is trying to make.
• There is NO new evidence to support the movement of more than 40 products from the covered to the non-covered list.

See Coalition Comments