[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: 42CFR486.308]



[Page 644-645]

 

                         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.  486.308  Designation of one OPO for each service area.



    (a) CMS designates only one OPO per service area. A service area is 

open for competition when the OPO for the



[[Page 645]]



service area is de-certified and all administrative appeals under Sec.  

486.314 are exhausted.

    (b) Designation periods--

    (1) General. An OPO is normally designated for a 4-year agreement 

cycle. The period may be shorter, for example, if an OPO has voluntarily 

terminated its agreement with CMS and CMS selects a successor OPO for 

the balance of the 4-year agreement cycle. In rare situations, a 

designation period may be longer, for example, a designation may be 

extended if additional time is needed to select a successor OPO to an 

OPO that has been de-certified.

    (2) Re-Certification. Re-certification must occur not more 

frequently than once every 4 years.

    (c) Unless CMS has granted a hospital a waiver under paragraphs

    (d) through (f) of this section, the hospital must enter into an 

agreement only with the OPO designated to serve the area in which the 

hospital is located.

    (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 listed 

for 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 

definitions of metropolitan statistical areas, 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.