42 CFR § 486.320 - Condition: Participation in Organ Procurement and Transplantation Network.

---
identifier: "/us/cfr/t42/s486.320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 486.320 - Condition: Participation in Organ Procurement and Transplantation Network."
title_number: 42
title_name: "Public Health"
section_number: "486.320"
section_name: "Condition: Participation in Organ Procurement and Transplantation Network."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "486"
part_name: "CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 273, 1302, 1320b-8, and 1395hh."
cfr_part: "486"
---


# 486.320 Condition: Participation in Organ Procurement and Transplantation Network.

After being designated, an OPO must become a member of, participate in, and abide by the rules and requirements of the OPTN established and operated in accordance with section 372 of the Public Health Service Act (42 U.S.C. 274). The term “rules and requirements of the OPTN” means those rules and requirements approved by the Secretary. No OPO is considered out of compliance with section 1138(b)(1)(D) of the Act or this section until the Secretary approves a determination that the OPO failed to comply with the rules and requirements of the OPTN. The Secretary may impose sanctions under section 1138 only after such non-compliance has been determined in this manner.