[Code of Federal Regulations] [Title 42, Volume 4] [Revised as of October 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR486.320] [Page 649-650] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY Subpart G_Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations Sec. 486.320 Condition: Participation in Organ Procurement and Transplantation Network. After being designated, an OPO must become a member of, participate in, [[Page 650]] and abide by the rules and requirements of the OPTN established and operated in accordance with section 372 of the Public Health Service Act (42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means those rules and requirements approved by the Secretary. No OPO is considered out of compliance with section 1138(b)(1)(D) of the Act or this section until the Secretary approves a determination that the OPO failed to comply with the rules and requirements of the OPTN. The Secretary may impose sanctions under section 1138 only after such non- compliance has been determined in this manner.