[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR486.308]

[Page 629]
 
                         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 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]