OPO Requirements for Certification

2811 - OPO Requirements for Certification (Rev. 111, Issued: 04-11-14, Effective: 04-11-14, Implemetation: 04-11-14) 42 CFR 486.303 details the following requirements that an OPO must meet in order to be certified by CMS. A qualified OPO: 1. 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 4 years as being a qualified OPO; 2. Be a non-profit entity that is exempt from Federal income taxation under section 501 of the Internal Revenue Code of 1986; 3. Have accounting and other fiscal procedures necessary to assure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non- renal organs provided to transplant hospitals; 4. Have an agreement with CMS, as the Secretary’s designated representative, to be reimbursed under Title XVIII for the procurement of kidneys; 5. Have been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005; 6. Have procedures to obtain payment for non-renal organs provided to transplant centers; 7. Agree to enter into an agreement with any hospital or CAH in the OPO’s service area, including a transplant hospital that requests an agreement; 8. Meet or have met the conditions for coverage for OPOs, including both the outcome measures and the process performance measures; and Meet the provisions of Titles XI, XVIII, and XIX of the Act, section 371(b) of the PHSA, and any other applicable Federal regulations.