June 8, 2024
The Alliance 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." The Alliance provided detailed comments and substantive recommendations focused on the following key areas in need of resolution and clarity:

  • Evidence, and the need for a consistent and equally applied methodology for the MACs assess and determine sufficient evidentiary support for coverage.
  • Reconsideration processes, and the imperative for a predictable, consistent process under which manufacturers can submit new evidence for MACs review in a timely fashion so that there is a pathway to gain coverage as new evidence becomes available.
  • Number of applications and treatment duration, with recommendations to more accurately reflect current peer-reviewed clinical evidence by increasing the number of applications allowed, and to recognize in the policy the needs of specific patient populations - like those with larger sized or deeper wounds - who will require more applications.
  • Implementation timeline, with a request that MACs provide an extended implementation period to avoid interruptions to patient care.

See Alliance recommendations to the MACs to achieve better balanced, fair and clinically accurate policies, below.

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