[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: 42CFR486.301]

[Page 614]
 
                         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. 486.301  Basis and scope.

    Source: 53 FR 6549, Mar. 1, 1988, unless otherwise noted. 
Redesignated at 60 FR 50447, Sept. 29, 1995.


    (a) Statutory Basis. (1) Section 1138(b) of the Act sets forth the 
requirements that an organ procurement organization must meet to have 
its organ procurement services to hospitals covered under Medicare and 
Medicaid. These include certification as a ``qualified'' organ 
procurement organization (OPO) and designation as the OPO for a 
particular service area.
    (2) Section 371(b) of the PHS Act sets forth the requirements for 
certification and the functions that a qualified OPO is expected to 
perform.
    (b) Scope. This subpart sets forth--
    (1) The conditions and requirements that an OPO must meet;
    (2) The procedures for certification and designation of OPOs; and
    (3) The terms of the agreement with CMS, and the basis for, and the 
effect of, termination of the agreement.
    (4) The requirements for an OPO to be recertified for the 
performance data cycle from January 1, 2002 through December 31, 2005.

[61 FR 19743, May 2, 1996, as amended at 66 FR 67111, Dec. 28, 2001]