42 U.S.C. § 1320b–8 — Hospital protocols for organ procurement and standards for organ procurement agencies

(a) Hospital requirements (1) A hospital or critical-access hospital meeting subchapter XVIII or XIX requirements may participate only if— (A) it has written protocols identifying potential organ donors that— (i) tell families about organ or tissue donation and their right to decline; (ii) require discretion and sensitivity toward the families’ circumstances, views, and beliefs; and (iii) require notice to the hospital’s designated organ-procurement agency; (B) if it performs transplants, it belongs to and follows the Organ Procurement and Transplantation Network (“Network”); and (C) it has an agreement only with its designated organ-procurement agency. (2)(A) The Secretary must waive (A)(iii) and (C) for a hospital wanting an agreement with another agency if the waiver is expected to increase donation and will ensure fair treatment of transplant referrals in both agencies’ service areas. (B) The Secretary may consider cost effectiveness, quality improvements, a post-December 28, 1992 metropolitan-statistical-area definition change affecting the designated agency, and the length and continuity of the hospital’s relationship with another agency. These factors cannot authorize a waiver that fails subparagraph (A). (C) The hospital must apply with information the Secretary requires. (D) Within 30 days, the Secretary must publicly announce each application and, before deciding, allow written comments during the 60 days beginning on publication. (3) For this subsection— (A) “agreement” means an agreement described in section 273(b)(3)(A); (B) “designated organ-procurement agency” means the agency designated under subsection (b) for the hospital’s service area; and (C) “organ” means a human kidney, liver, heart, lung, pancreas, and any other human organ or tissue the Secretary specifies. (b) Agency payment standards (1) The Secretary must allow payment under subchapter XVIII or XIX for organ-procurement costs attributable to an agency only if it— (A) is a qualified organization operating under a section 273(a) grant, or was certified or recertified by the Secretary within the previous 2 years (4 years when appropriate because of past practices); (B) meets applicable subchapter requirements; (C) meets the Secretary’s performance standards; (D) belongs to and follows the Network; (E) allocates organs in its service area and nationally under medical criteria and Network policies; and (F) is designated by the Secretary as an organization whose payments may be treated as organ-procurement costs. (2) The Secretary may designate no more than one organization for each service area described in section 273(b)(1)(E).