[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: 42CFR486.307]

[Page 618]
 
                         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. 486.307  OPO service area size designation and documentation requirements.

    (a) General documentation requirement. An OPO must make available to 
CMS documentation verifying that the OPO meets the requirements of 
paragraphs (b) through (d) of this section at the time of application 
and throughout the period of its designation.
    (b) Boundary designation. The defined service area either includes 
an entire Metropolitan Statistical Area or a New England County 
Metropolitan Area as specified by the Director of the Office of 
Management and Budget or does not include any part of such an area.
    (c) Service area location and characteristics. An OPO must precisely 
define and document a proposed service area's location through the 
following information:
    (1) The names of counties (or parishes in Louisiana) served or, if 
the service area includes an entire State, the name of the State.
    (2) Geographic boundaries of the service area for which U.S. 
population statistics are available.
    (3) Total population in service area.
    (4) The number of and the names of acute care hospitals in the 
service area with an operating room and the equipment and personnel to 
retrieve organs.
    (d) Sufficient size requirements. (1) Before January 1, 1996, an OPO 
must demonstrate that it can procure organs from at least 50 potential 
donors per calendar year or that its service area comprises an entire 
State.
    (2) Beginning January 1, 1996, an OPO must meet at least one of the 
following requirements:
    (i) Its service area must include an entire State or official U.S. 
territory.
    (ii) It must either procure organs from an average of at least 24 
donors per calendar year in the 2 years before the year of redesignation 
or request and be granted an exception to this requirement under 
paragraph (d)(3) or (d)(4) of this section.
    (iii) In the case of an OPO operating exclusively in a noncontiguous 
U.S. State, a U.S. territory, or a U.S. commonwealth, such as Hawaii or 
Puerto Rico, it must procure organs at the rate of 50 percent of the 
national average of all OPOs for kidney procurement per million 
population and for kidney transplantation per million population.
    (iv) If it is an entity that has not been previously designated as 
an OPO, it must demonstrate that it can procure organs from at least 50 
potential donors per calendar year.
    (3) CMS may grant an OPO an exception to paragraph (d)(2)(ii) of 
this section if the OPO can demonstrate that--
    (i) It failed to meet the requirement because of unusual 
circumstances beyond its control;
    (ii) It has historically maintained a service area of sufficient 
size to meet the criterion in paragraph (d)(2)(ii) of this section; and
    (iii) It has a specific plan to meet the size criterion in paragraph 
(d)(2)(ii) of this section in the future.
    (4) During the 1996 redesignation process only, CMS may grant an 
exception to paragraph (d)(2)(ii) of this section to an OPO that can 
demonstrate that--
    (i) It meets the performance criteria in Sec. 486.310(b); and
    (ii) It has a specific plan to meet the service area size criterion 
in paragraph (d)(2)(ii) of this section by the 1998 redesignation 
period.

[61 FR 19744, May 2, 1996]