On Friday, April 11, the Centers for Medicare & Medicaid Services (CMS) announced that the final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers will now take effect on January 1, 2026.

As part of our continued advocacy efforts, AATB—alongside AOPO and EBAA—sent a joint letter today to newly confirmed FDA Commissioner Dr. Marty Makary urging the immediate rescission of two guidance documents issued as final on January 6, 2025.

AATB commends Representatives John Moolenaar (R-MI) and Debbie Dingell (D-MI) for reintroducing the Shandra Eisenga Human Cell and Tissue Product Safety Act, a vital piece of legislation aimed at preventing tuberculosis (TB) infections linked to tissue transplants.

Earlier this week, AATB representatives and members had the incredible opportunity to visit Capitol Hill, to advocate for key issues impacting the tissue banking community.

AATB is pleased to announce that we will no longer charge institutional members a supplemental fee for satellite site inspections conducted as part of the routine three-year accreditation cycle. 

The FDA has announced a revised implementation date of May 4, 2025, for its recently issued guidance documents.

On Friday, January 24, 2025, all seven Medicare Administrative Contractors (MACs) announced a delay in implementing final skin substitute Local Coverage Determinations (LCDs). Initially set to take effect on February 12, 2025, the implementation date has been postponed to April 13, 2025.

In light of recent regulatory developments, it is essential for stakeholders in the tissue banking community to stay informed about potential changes to FDA guidance documents.

On January 6, 2025, the FDA released six guidance documents, including two final documents: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance) and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance).