[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: 42CFR486.316]



[Page 648-649]

 

                         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.  486.316  Re-certification and competition processes.



    (a) Re-Certification of OPOs. An OPO is re-certified for an 

additional 4 years and its service area is not opened for competition 

when the OPO:

    (1) Meets all 3 outcome measure requirements at Sec.  486.318; and

    (2) Has been shown by survey to be in compliance with the 

requirements for certification at Sec.  486.303, including the 

conditions for coverage at Sec.  486.320 through Sec.  486.348.

    (b) De-certification and competition. If an OPO does not meet all 3 

outcome measures as described in paragraph (a)(1) of this section or the 

requirements described in paragraph (a)(2) of this section, the OPO is 

de-certified. If the OPO does not appeal or the OPO appeals and the 

reconsideration official and CMS hearing officer uphold the de-

certification, the OPO's service area is opened for competition from 

other OPOs. The de-certified OPO is not permitted to compete for its 

open area or any other open area. An OPO competing for an open service 

area must submit information and data that describe the barriers in its 

service area, how they affected organ donation, what steps the OPO took 

to overcome them, and the results.

    (c) Criteria to compete. To compete for an open service area, an OPO 

must meet the criteria in paragraph (a) of this section and the 

following additional criteria:

    (1) The OPO's performance on the donation rate outcome measure and 

yield outcome measure is at or above 100 percent of the mean national 

rate averaged over the 4 years of the re-certification cycle; and

    (2) The OPO's donation rate is at least 15 percentage points higher 

than the donation rate of the OPO currently designated for the service 

area.

    (3) The OPO must compete for the entire service area.

    (d) Criteria for selection. CMS will designate an OPO for an open 

service area based on the following criteria:

    (1) Performance on the outcome measures at Sec.  486.318;

    (2) Relative success in meeting the process performance measures and 

other conditions at Sec. Sec.  486.320 through 486.348;

    (3) Contiguity to the open service area.

    (4) Success in identifying and overcoming barriers to donation 

within its own service area and the relevance of those barriers to 

barriers in the open area. An OPO competing for an open service area 

must submit information and data that describe the barriers in its 

service area, how they affected organ donation, what steps the OPO took 

to overcome them, and the results.

    (e) No OPO applies. If no OPO applies to compete for a de-certified 

OPO's



[[Page 649]]



open area, CMS may select a single OPO to take over the entire open area 

or may adjust the service area boundaries of two or more contiguous OPOs 

to incorporate the open area. CMS will make its decision based on the 

criteria in paragraph (d) of this section.



           Organ Procurement Organization Outcome Requirements