AATB Members Approve New Bylaws and Organizational Transition

AATB members have voted to approve the proposal to repeal and replace the AATB Bylaws. This important milestone establishes the Association for Advancing Tissue and Biologics as our new parent organization and transitions the historic American Association of Tissue Banks into the AATB Foundation.

This milestone strengthens our collective ability to advocate for tissue institutions, influence policy, and advance the field—while maintaining our unwavering commitment to the safety, quality, and availability of human tissue for transplantation.

Addressing Key Industry Issues

AATB is actively engaged in responding to two pressing issues that directly impact our members and the tissue community:

1. FDA Sepsis Interpretation and Donor Eligibility
   In August, the FDA inspected an AATB-accredited member establishment and issued a Form 483 focused on the agency’s interpretation of sepsis-related requirements outlined in the 2007 FDA Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) guidance.
   
   This interpretation of these old sepsis criteria and diagnosis would significantly reduce the number of eligible tissue donors. AATB is working closely with outside counsel to evaluate all legal, regulatory, and legislative options and will continue to advise members on next steps.
    
2. CMS 2026 Medicare Physician Fee Schedule
   On October 31, CMS released the 2026 Medicare Physician Fee Schedule (PFS), setting reimbursement for skin substitutes used in outpatient settings at $127.28 per cm², regardless of product classification (PMA, 510(k), or 361 HCT/Ps).
   
   AATB supports reasonable reforms to reimbursement for skin substitutes. However, this rate could negatively impact patient access and stifle innovation for these life-transformative tissue products. AATB is again working with external experts to assess all available options and determine the most effective course of action.

Get Involved

• Join the new AATB Regulatory Affairs Council to stay engaged and informed in these ongoing initiatives.
• Attend the 2026 AATB Capitol Hill Fly-In on February 25, 2026, to advocate directly for our shared mission.

Looking Ahead

Over the coming months, AATB programs and activities, including standards and accreditation, certification, and education, will transition seamlessly to the Association for Advancing Tissue and Biologics, along with our dedicated staff. For members and partners, day-to-day operations and engagement opportunities will remain consistent.

Thank you for your continued support and commitment to advancing our profession and the patients we serve.