Organ Procurement Organizations (OPOs) – Citations - Statutory

2810 - Organ Procurement Organizations (OPOs) – Citations - Statutory Authority (Rev. 111, Issued: 04-11-14, Effective: 04-11-14, Implemetation: 04-11-14) Section §1138 (b)(1) of the Social Security Act (the Act) authorizes the Secretary to provide payment under Medicare or Medicaid to hospitals/CAHs and transplant centers for the cost of organs procured from organ procurement organizations (OPOs) only if the organization: • Is a qualified OPO operating under a grant made under §371(a) of the Public Health Service Act (PHSA), or has been certified or recertified by the Secretary within the previous four years as meeting the standards to be a qualified OPO; • Meets applicable requirements of Medicare or Medicaid for OPOs; • Meets performance-related standards prescribed by the Secretary; • Is a member of and abides by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) designated by the Secretary pursuant to §372 of the PHSA. (The United Network for Organ Sharing (UNOS) operates the OPTN under a contract with the PHS); • Allocates organs, within its service area and nationally, in accordance with medical criteria and the policies of the OPTN; and • Is designated or re-designated by the Secretary as an OPO under §1138 of the Act. To be designated as the OPO for a service area, an organization must at the time of application and throughout the period of designation meet these statutory requirements. Further, the Act requires that the Secretary may not designate more than one OPO for each service area, as described in §371 (b)(1)(E) of the PHSA and §1138 (b)(2) of the Act.