[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: 42CFR486.302]

[Page 624-625]
 
                         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. 486.302  Definitions.

    As used in this subpart, the following definitions apply:
    Certification or recertification means a CMS determination that an 
entity meets the standards for a qualified OPO at Sec. 486.304 of this 
subpart and is eligible for designation if it meets the additional 
conditions for designation at Sec. Sec. 486.306 and 486.308. No payment 
ensues from certification alone.

[[Page 625]]

    Designation or redesignation means CMS approval of an OPO for 
Medicare and Medicaid payment purposes under section 1138(b)(1)(F) of 
the Act. The terms are used interchangeably except when otherwise 
specifically indicated.
    Entire standard metropolitan statistical area means a metropolitan 
statistical area, a consolidated metropolitan statistical area, or a 
primary statistical area listed in the State and Metropolitan Area Data 
Book published by the U.S. Bureau of the Census.
    Open area means a service area for which CMS has notified the public 
that it is accepting applications for designation.
    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestines (or multivisceral organs).
    Organ procurement organization means an organization that performs 
or coordinates the performance of retrieving, preserving and 
transporting organs and maintains a system of locating prospective 
recipients for available organs.
    Potential donor means a person who dies in circumstances (causes and 
conditions of death, and age at death) that are generally acceptable for 
donation of at least one solid organ if the donor can be identified 
timely and permission for donation can be obtained.
    Service area means a geographical area of sufficient size to assure 
maximum effectiveness in the procurement and equitable distribution of 
organs and that either includes an entire standard metropolitan 
statistical area or does not include any part of such an area and that 
meets the standards of this subpart.
    Transplant center means a hospital certified by Medicare to furnish 
directly, for a specific organ(s), transplant and other medical and 
surgical specialty services required for the care of transplant 
patients.

[53 FR 6549, Mar. 1, 1988, as amended at 59 FR 46514, Sept. 8, 1994. 
Redesignated and amended at 60 FR 50447, 50448, Sept. 29, 1995; 66 FR 
39938, Aug. 1, 2001]