Extra! Extra! Read All About the AATB Updates!
Welcome back! If you’ve been following “AATB” in our tissue banking industry, they’ve had some significant updates! Let’s dive in!
Back in November 2025, the American Association of Tissue Banks (AATB) met, and approval was obtained to update their previous bylaws and organizational change. With this, the Association for Advancing Tissue and Biologics [1] become the new parent organization building on their foundation. The recognition of the changing landscape of our industry, regenerative medicine, and the growing importance of biologics in patient treatment continues to move AATB at the forefront of innovation, advocacy, and scientific leadership. This transformation isn’t just cosmetic, it reflects AATB’s broader and collaborative efforts to the future of tissue and biologic therapeutics, organizing and advocating for tissue institutions, influencing policy with regulatory excellence, and their commitment to advancing the human tissue for transplantation for safety, quality, and availability to patients.
The next big-ticket item we’ve all been following is the Centers for Medicare and Medicaid Services (CMS) since they released the Medicare Physician Fee Schedule (PFS) Final Rule where the Agency published the payment rate of approximately $127.14/cm squared [2]. The PFS has a significant effect on our tissue banking industry, creating considerable disruption and uncertainty. With the implementation of this rule scheduled for January 2026, many in the industry are anticipating further challenges as they adapt to this new reimbursement requirement [3] . On December 4, 2025, AATB reached out to Dr. Mehmet Oz, Administrator of CMS, urging the Agency to revise the payment rate emphasizing the critical role of our industry’s medical professionals who ensure safe and effective transplantation, as well as the need to align reimbursement policies with the true value and complexity of making these products, as ultimately patients will suffer without access to these lifesaving products [4].
The last item we’ve been following is AATB’s letter to the Commissioner of the Food and Drug Administration (FDA), Dr. Marty Makary. Concerns arose as an accredited AATB organization was recently issued an FDA 483 observation over the Agency’s approach to sepsis in donor eligibility determination. On December 5, 2025, AATB reached out to the FDA requesting a meeting to present their concerns in more detail and for a discussion on evidence-based policy solutions to prevent infectious disease transmission.
Key points for discussion [4]:
Medical Directors Are Best Situated to Evaluate Risk at the Time of a Patient’s Death: The FDA’s new approach requires tissue establishment Medical Directors to exclude donors with any documented sepsis, regardless of context, which oversimplifies risk assessment and ignores the nuanced critical clinical judgment that they can provide.
Concerns with the 2025 Draft Sepsis Guidance: The application of the new interpretation amplifies concerns with the 2025 Draft Sepsis guidance, risking unintended consequences if finalized without collaboration with stakeholders, like AATB.
Sepsis as a Surrogate for Transmissible Systemic Infection is Flawed: Treating any sepsis diagnosis as indicative of transmissible infection is flawed as sepsis may not always result from a transmissible disease, potentially excluding safe donors unnecessarily.
Impact on Donor Availability and Patient Access: Strict exclusion based on sepsis or SIRS criteria could reduce donor availability significantly, severely impacting tissue supply without a proven increase in recipient safety.
As we wait for responses from CMS and the FDA, the Association for Advancing Tissue and Biologics continues seeking regulatory clarity and remains active in their government advocacy. With their commitment to transparency, collaboration, and leadership, these initiatives will continue to be crucial in shaping policies, supporting medical professionals and establishments, and ensuring that patients have access to the best possible treatments.
Check back as we continue following our industry news and updates!
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[4] https://www.aatb.org/government-advocacy-correspondences