[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR486.308] [Page 618-619] 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 SUPPLIERS--Table of Contents Subpart G--Conditions for Coverage: Organ Procurement Organizations Sec. 486.308 Condition: Participation in organ procurement and transplantation network. In order to be designated as the OPO for its service area, and to continue to be the designated OPO once designated, an OPO must be a member of, have a written agreement with, and abide by the rules of the OPTN established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274). The term ``rules of the OPTN'' means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the [[Page 619]] PHS Act. No OPO is considered to be out of compliance with section 1138(b)(1)(D) of the Act or this section unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the entity from the OPTN and also has notified the entity in writing. [59 FR 46516, Sept. 8, 1994. Redesignated and amended at 60 FR 50447, 50448, Sept. 29, 1995]