[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR486.318]

[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. 486.318  Changes in ownership or service area.

    (a) OPO requirements. (1) A designated OPO considering a change in 
ownership or in its service area must notify CMS before putting it into 
effect. This notification is required to ensure that the entity, as 
changed, will continue to satisfy Medicare and Medicaid requirements. A 
change in ownership takes place if there is the merger of one entity 
into another or the consolidation of one entity with another.
    (2) A designated OPO considering a change in its service area must 
obtain prior CMS approval. In the case of a service area change that 
results from a change of ownership due to merger or consolidation, the 
entities must submit anew the information required in an application for 
designation, or other written documentation CMS determines to be 
necessary for designation.
    (b) CMS requirements. (1) If CMS finds that the entity has changed 
to such an extent that it no longer satisfies the prerequisites for OPO 
designation, CMS may terminate the OPO's agreement and declare the OPO's 
service area to be an open area.
    (2) If CMS finds that the changed entity continues to satisfy the 
prerequisites for OPO designation, the period of designation of the 
changed entity is the remaining designation term of the OPO that was 
reorganized. If more than one designated OPO is involved in the 
reorganization, the remaining designation term is ordinarily the longest 
of the remaining periods. CMS may determine, however, that a shorter 
period applies if it decides that a shorter period is in the best 
interest of the Medicare and Medicaid programs. The performance 
standards of Sec. 486.310 apply at the end of this remaining period.

[59 FR 46517, Sept. 8, 1994. Redesignated and amended at 60 FR 50447, 
50448, Sept. 29, 1995]