42 C.F.R. § 486.304 – Requirements for designation.

(a) Designation is a condition for payment. Payment may be made under the Medicare and Medicaid programs for organ procurement costs attributable to payments made to an OPO by a hospital only if the OPO has been designated by CMS as an OPO.
(b) An OPO must be certified as a qualified OPO by CMS under 42 U.S.C. 273(b) and § 486.303 to be eligible for designation.
(c) An OPO must enter into an agreement with CMS in order for the organ procurement costs attributable to the OPO to be reimbursed under Medicare and Medicaid.