CMS Withdraws LCDs for Skin Substitutes After Hearing Concerns From AATB

The three skin substitute LCDs/LCAs, entitled "Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers," and proposed by CGS Administrators, LLC, Novitas Solutions, Inc., and First Coast Service Options, Inc. will not go into effect on October 1, 2023, as previously announced.

AATB and the AATB Tissue Policy Group sent letters dated September 8, 2023, to these 3 CMS Medicare Administrative Contractors (MACs), which expressed its concerns that the LCD will restrict access to critical allografts used in wound care. The letter urged the MACs to update the LCA to provide payment for appropriately regulated allografts in the Group 3 set of HCPCS codes considered “non-covered’, to provide at least 18 months for manufacturers to obtain proof of regulatory status, to revise the application limit to be consistent with patients’ clinical needs, and to postpone the proposed implementation date until at least January 1, 2024.

AATB also spoke on behalf of its accredited banks and members during a “listening session” on the matter hosted by CMS on September 13, 2023, and emphasized the points that were made in the letters.

It is expected that the MACs will issue a new proposed LCD, which will be published for comment and presented at an open meeting in the near future. AATB will continue to provide updates to its members and accredited tissue banks. AATB will continue to provide updates to its members and accredited tissue banks.