OPO Designation Requirements

2812 - OPO Designation Requirements (Rev. 111, Issued: 04-11-14, Effective: 04-11-14, Implemetation: 04-11-14) An OPO must be designated by CMS and must enter into an agreement with CMS in order for the OPO to be reimbursed under Medicare and Medicaid for the costs of organ procurement. 42 CFR 486.306(b) and (c) details the requirements that an OPO must meet for service area designation, service area location, and characteristics. 42 CFR 486.308 specifies that CMS designates only one OPO per service area and that the service area is only open for competition after the OPO designated for that area is de- certified and all administrative appeals have been completed under §486.314, or the OPO voluntarily withdraws from the program. A designated OPO may only change its service area boundaries as a result of a merger or consolidation with another OPO after advance approval by CMS as noted in §486.310 (a). An OPO must compete for an entire service area according to §486.316(c)(3). An OPO is normally designated for a 4-year agreement cycle. In the case of a voluntary termination of its agreement, CMS will open the service area for competition to fill the remaining term of the 4-year agreement cycle. A designation period may be longer than the 4-year agreement cycle in instances where CMS requires a longer period of time to select a successor to an OPO that has been de-certified or has voluntarily terminated.