Vascularized Composite Tissue Allografts (VCA): the Policy Side

Abstract

In July 2013, the Secretary of Health amended the National Organ Transplant Act of 1986 to designate vascularized composite tissue allografts (VCAs) as organs. The definition of a VCA as an organ required that all nine criteria published in the Final Rule were fulfilled. VCAs meeting the definition of an organ would henceforth come under the oversight of the Organ Procurement Transplant Network (OPTN) and were required to develop and be in compliance with policies and bylaws as for traditional organ transplantation. The implementation date for the Final Rule modification was July 3, 2014. The OPTN and the United Network of Organ Sharing (UNOS) convened a multidisciplinary VCA committee to spearhead developing the first policies relevant to VCA. Described in this article are the policies that have been developed and the necessary bylaw changes required. These include requirements for OPTN/UNOS membership for VCA programs, specific policies for the authorization of potential donors of VCAs, allocation algorithms for VCA donors, mandatory data submission requirements, and guidance documents for the donation and authorization process, and for potential VCAs from living donors. The OPTN/UNOS Board approved the initial policies and bylaw changes in June 2014 to meet the deadline for implementation of the Final Rule modification. Since then, further modifications of the first policies and bylaws have occurred which are also described.