[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: 42CFR486.310]

[Page 629-630]
 
                         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. 486.310  Condition: Adherence to performance standards.

    (a) Standards before January 1, 1996. Before January 1, 1996, OPOs 
must meet the following performance standards:
    (1) Each OPO must procure within its service area a minimum ratio of 
23 cadaveric kidneys per million population of its service area for each 
12-month period surveyed.
    (2) Each OPO must provide a minimum ratio of cadaveric kidneys 
procured in its service area and transplanted (either locally or 
exported and transplanted) of 19 cadaveric kidneys per million 
population of its service area for each 12-month period surveyed.
    (b) Standards beginning on January 1, 1996. Except as specified in 
paragraph (c) of this section, each OPO must achieve at least 75 percent 
of the national mean for four of the following five performance 
categories, averaged over the 2 calendar years before the year of 
redesignation:
    (1) Number of actual donors per million population.
    (2) Number of kidneys recovered per million population.
    (3) Number of extrarenal organs recovered per million population.
    (4) Number of kidneys transplanted per million population.
    (5) Number of extrarenal organs transplanted per million population.
    (c) Exceptions and exemptions--(1) Exception based on location. OPOs 
operating exclusively in a noncontiguous U.S. State, a U.S. territory, 
or a U.S. commonwealth, such as Hawaii or Puerto Rico, may be granted an 
exception from the performance standards of paragraph (b) of this 
section because of special geographically related characteristics, such 
as difficulty in transporting organs to the mainland, that impede 
satisfaction of the national rate of organ procurement. They must meet a 
standard of 50 percent of the national average of all OPOs for kidneys 
recovered and transplanted per million population.
    (2) Exception because of lack of competition for a service area. CMS 
may continue to designate an OPO that does not meet the standards under 
paragraph (b) of this section for a service area if no OPO that meets 
the performance and qualification requirements is willing to accept 
responsibility for the service area and if the designated OPO

[[Page 630]]

submits an acceptable corrective action plan in accordance with 
paragraph (d) of this section.
    (3) Exception for 1996 transition period. During the 1996 
designation period only, CMS may continue to designate for a service 
area an OPO that does not meet the standards under paragraph (b) of this 
section if the OPO:
    (i) Meets three of the criteria in paragraphs (b)(1) through (b)(5) 
of this section; and
    (ii) Submits an acceptable corrective action plan in accordance with 
paragraph (d) of this section.
    (d) Corrective action plans and corrected information--(1) 
Corrective action plans. (i) If a designated OPO does not meet the 
standards of paragraph (a) of this section, it may submit to the 
appropriate CMS regional office a corrective action plan explaining why 
it failed to meet them and specifying the actions it will take to ensure 
it meets those standards in the future.
    (ii) CMS will not accept corrective action plans from an OPO for 
failure to meet the standards specified in paragraph (b) of this section 
unless the OPO continues to be designated under paragraph (c)(2) or 
(c)(3) of this section.
    (2) Corrected information. An OPO may request correction of the 
information required by Sec. 486.306(e) from CMS throughout the two-
year designation period. CMS will evaluate the OPO's request and may 
seek input from other sources, such as hospital personnel, neighboring 
OPOs, the OPTN contractor, and the Census Bureau as necessary to verify 
the OPO's information before making the changes requested by the OPO. In 
addition, CMS will notify an OPO if it does not meet the performance 
standards based on the information reported. Any OPO so notified may 
provide corrected information for consideration within 30 days of 
receipt of a notice of failure to meet the standards.

[59 FR 46516, Sept. 8, 1994. Redesignated and amended at 60 FR 50447, 
50448, Sept. 29, 1995; 61 FR 19744, May 2, 1996]