[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: 42CFR486.310]



[Page 645-646]

 

                         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.  486.310  Changes in control or ownership or service area.



    (a) OPO requirements.

    (1) A designated OPO considering a change in control (see Sec.  

413.17(b)(3)) or ownership or in its service area must notify CMS before 

putting it into effect. This notification is required to ensure that the 

OPO, if changed, will continue to satisfy Medicare and Medicaid 

requirements. The merger of one OPO into another or the consolidation of 

one OPO with another is considered a change in control or ownership.

    (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 control or ownership due to merger or 

consolidation, the OPOs must resubmit the information required in an 

application for designation. The OPO must provide information specific 

to the board structure of the new organization, as well as operating 

budgets, financial information, and other written documentation CMS 

determines to be necessary for designation.

    (b) CMS requirements.



[[Page 646]]



    (1) If CMS finds that the OPO has changed to such an extent that it 

no longer satisfies the requirements for OPO designation, CMS may de-

certify the OPO and declare the OPO's service area to be an open area. 

An OPO may appeal such a de-certification as set forth in Sec.  486.314. 

The OPO's service area is not opened for competition until the 

conclusion of the administrative appeals process.

    (2) If CMS finds that the changed OPO continues to satisfy the 

requirements for OPO designation, the period of designation of the 

changed OPO is the remaining portion of the 4-year term of the OPO that 

was reorganized. If more than one designated OPO is involved in the 

reorganization, the remaining designation term is the longest of the 

remaining periods unless CMS determines that a shorter period is in the 

best interest of the Medicare and Medicaid programs. The changed OPO 

must continue to meet the requirements for certification at Sec.  

486.303 throughout the remaining period.



                  Re-Certification and De-Certification