Medicare and Medicaid programs; organ procurement and transplantation network rules and membership actions--HCFA....

This notice sets forth the Secretary's interpretation of certain provisions of section 1138 of the Social Security Act. That section requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act. Section 1138 also requires that for organ procurement costs attributable to payments to an Organ Procurement Organization (OPO) to be paid by Medicare or Medicaid, the OPO must be a member of and abide by the rules and requirements of the OPTN. No other entity (for example, a histocompatibility laboratory) is required to be a member of or abide by the rules of the OPTN under the provisions of the statute. This notice states that no rule, requirement, policy, or other issuance of the OPTN will be considered to be a "rule or requirement" of the Network within the meaning of section 1138 unless the Secretary has formally approved that rule. It also provides that no action of the OPTN to deny an applicant or member membership status in the OPTN will be considered effective under section 1138 unless the Secretary has ratified that action.