[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: 42CFR486.316]

[Page 620-621]
 
                         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. 486.316  Designation of one OPO for each service area.

    (a) CMS designates only one OPO per service area. Applications for 
designation are accepted only during a period when the service area is 
an open area. A service area is open for competition once the existing 
designation period has expired, when the existing designated status of 
the OPO for that service area has been terminated, or when no OPO has 
been designated for the area. CMS may also declare the service area open 
in the event an OPO ceases to operate or CMS has reasonable ground for 
anticipating it will cease to operate. In cases of urgent need (such as 
evidence of medically or ethically unsound practices), CMS may terminate 
its agreement with an OPO immediately. The service area remains open 
until an OPO is designated for it. If more than one organization applies 
and substantially meets the requirements of Sec. 486.306 in a given 
service area, CMS considers other factors in reaching a decision 
concerning which organization to designate. These factors follow:
    (1) Prior performance, including the previous year's experience in 
terms of the number of organs retrieved and wasted and the average cost 
per organ;
    (2) Actual number of donors compared to the number of potential 
donors;
    (3) The nature of relationships and degree of involvement with 
hospitals in the organization's service area;
    (4) Bed capacity associated with the hospitals with which the 
organizations have a working relationship;
    (5) Willingness and ability to place organs within the service area; 
and
    (6) Proximity of the organization to the donor hospitals.
    (b) An organization that applies to CMS to be the designated OPO for 
its service area and that is not designated may appeal its 
nondesignation under part 498 of this chapter.
    (c) After January 1, 1996, a hospital must enter into an agreement 
only with the OPO designated to serve the area in which the hospital is 
located unless CMS has granted the hospital a waiver under paragraphs 
(d) through (g) of this section to be serviced by another OPO.
    (d) If CMS changes the OPO designated for an area, hospitals located 
in that area must enter into agreements with the newly designated OPO or 
submit a request for a waiver in accordance with paragraph (e) of this 
section within 30 days of notice of the change in designation.
    (e) A hospital may request and CMS may grant a waiver permitting the 
hospital to have an agreement with a designated OPO other than the OPO 
designated for the service area in which the hospital is located. To 
qualify for a waiver, the hospital must submit data to CMS establishing 
that--
    (1) The waiver is expected to increase organ donations; and
    (2) The waiver will ensure equitable treatment of patients referred 
for

[[Page 621]]

transplants within the service area served by the hospital's designated 
OPO and within the service area served by the OPO with which the 
hospital seeks to enter into an agreement.
    (f) In making a determination on waiver requests, CMS considers:
    (1) Cost effectiveness;
    (2) Improvements in quality;
    (3) Changes in a hospital's designated OPO due to changes in the 
metropolitan service area designations, if applicable; and
    (4) The length and continuity of a hospital's relationship with an 
OPO other than the hospital's designated OPO.
    (g) A hospital may continue to operate under its existing agreement 
with an out-of-area OPO while CMS is processing the waiver request. If a 
waiver request is denied, a hospital must enter into an agreement with 
the designated OPO within 30 days of notification of the final 
determination.

[59 FR 46517, Sept. 8, 1994. Redesignated and amended at 60 FR 50447, 
50448, Sept. 29, 1995; 61 FR 19745, May 2, 1996]