June 8, 2024
The Coalition submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on "Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." Coalition recommendations spanned a broad range of issues, including: 

  • Evidence: the Coalition recommended that the MACs provide the GRADE criteria or protocols utilized to evaluate CTP evidence prior to this policy becoming finalized
  • Reconsideration processes: the Coalition recommended that the MACs remove the product-by-product evaluation from the LCD and instead place in an Appendix or in the LCA so the entire LCD does not have to be reopened every time new evidence is reviewed; urged the MACs to provide an efficient and timely process for manufacturers to submit additional published evidence or other data to support movement of products located within the non-covered Group 3 to the covered Group 2 list.
  • Implementation timeline: the Coalition recommended that patients on a current plan of care protocol when the policy is implemented be grandfathered so they are able to complete the plan of care established by their clinician based on current LCD language. 

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