Organ Procurement Organizations (OPOs)

10.2.1.10 - Organ Procurement Organizations (OPOs) (Rev. 10868; Issued: 07-14-21; Effective: 08-13-21; Implementation: 08-13-21) A. General Background Information An OPO is an organization that performs or coordinates the procurement, preservation, and transport of organs and maintains a system for locating prospective recipients for available organs. An OPO must have been certified as a qualified OPO by CMS under 42 U.S.C. 273(b) and § 486.303 to be eligible for designation. In order to be certified as a qualified OPO, an OPO must have received a grant under 42 U.S.C. 273(a) or have been certified or re-certified by the Secretary within the previous four years as being a qualified OPO. Under the statute, no new OPOs can enroll into the Medicare program B. Re-Certification An OPO is 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. Re-certification must occur not more frequently than once every 4 years. The SOG Location is responsible for conducting the re- certification surveys every 4 years; the OPO must sign a new provider agreement (Form CMS-576A) and participate in the Organ Procurement and Transplantation Network. (See CMS Pub. 100-07, chapter 2, sections 2810 and 2811.) C. Change in Control/Ownership or Service Area OPOs can undergo a change in control or ownership or service area (§ 486.310). The merger of one OPO into another or the consolidation of one OPO with another is considered a change in control or ownership. The OPO must notify CMS before implementing a change in ownership or control or a change in its service area. The OPO must provide the SOG Location with information that is specific to the board structure of the new organization, as well as operating budgets, financial information and other documentation that the SOG Location determines to be necessary. The OPO must also submit a revised Form CMS-855 to the MAC for review and a recommendation of approval from the SOG Location. When the SOG Location receives notification of a prospective change in control or ownership for a designated OPO, the SOG Location must determine (based upon the documents and information submitted) that the operation of the OPO will continue uninterrupted during and following the change. For any change of ownership or control, a new CMS Form-576 must be signed. The instructions in the previous paragraph are in addition to, and not in lieu of, those pertaining to changes of ownership and referrals to SOG Locations in sections 10.6 and 10.6.1 et seq. of this chapter. D. Additional Information For more information on OPOs, refer to: • Section 1138 of the Social Security Act • 42 CFR § 486.301 - § 486.360 • Pub. 100-07, chapter 2, sections 2810 – 2821 For guidance on the appropriate contractor jurisdiction for incoming OPO applications, see CMS Pub. 100-04, chapter 1, section 20. Note that a hospital-based OPO must enroll separately, be separately certified, and sign its own provider agreement.