[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.306]



[Page 644]

 

                         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 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.306  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) Service area designation. The defined service area either 

includes an entire metropolitan statistical area or a New England county 

metropolitan statistical 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 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.

    (3) The number and the names of all hospitals and critical access 

hospitals in the service area that have both a ventilator and an 

operating room.