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Medicare Conditions of Participation
Specialized Services Furnished by Suppliers

10.) Specialized Services Furnished by Suppliers

        a.) Organ Procurement Organizations

An organization procurement organization (OPO) is an organization that performs or coordinates the procurement, preservation, and transport of organs and maintains a system for locating prospective beneficiaries for available organs.212 

If an OPO wishes to terminate its agreement, it must send CMS written notice of its intent to terminate its agreement and the proposed effective date.213 During the term of the agreement, CMS may terminate an agreement with an OPO if it no longer meets the requirements for certification. If an OPO’s de-certification is due to involuntary termination or non-renewal of its agreement with CMS, the OPO may appeal the decertification on substantive and procedural grounds.214

An OPO may be recertified if it complies with regulatory requirements.215 There is a process of competition between OPOs if an OPO becomes decertified and its service area becomes open.

                i.) Conditions of coverage

An OPO must comply with the following conditions of coverage:

  • An OPO must meet all outcome measures of organ donation.216
  • An OPO must become a member of the Organ Procurement and Transplantation Network after becoming certified.217
  • An OPO must have a written agreement with Medicare and Medicaid participating hospitals and critical access hospitals in its service area.218 OPOs must also have arrangements to cooperate with tissue banks that have agreements with hospitals and critical access hospitals.
  • An OPO must provide individually-identifiable, hospital-specific organ donation and transplantation data to the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Beneficiaries, and the Department of Health and Human Services.219
  • An OPO must establish and use an electronic information management system to maintain the required medical, social and identifying information for every donor and transplant recipient and develop procedures to ensure the confidentiality and security of the information.220
  • An OPO must encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of potential donor families.221 An OPO must have a written protocol to ensure that the individual responsible for making the donation decision are informed of their options to donate organs or tissues or to decline to donate.
  • The OPO must have written protocols for donor evaluation and management and organ placement and recovery that meet standards of practice and are designed to maximize organ quality and number of donors and organs.222
  • An OPO must arrange for testing of organs for infectious disease and tissue typing of organs according to current standards of practice.223
  • An OPO must develop a comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all donation services.224 An OPO’s QAPI program must satisfy standards relating to the program’s components, death record reviews, and adverse events.



  • 212. 42 C.F.R. § 486.302
  • 213. 42 C.F.R. § 486.312
  • 214. 42 C.F.R. § 486.314
  • 215. 42 C.F.R. § 486.316
  • 216. 42 C.F.R. § 486.318
  • 217. 42 C.F.R. § 486.320
  • 218. 42 C.F.R. § 486.322
  • 219. 42 C.F.R. § 486.328
  • 220. 42 C.F.R. § 486.330
  • 221. 42 C.F.R. § 486.342
  • 222. 42 C.F.R. § 486.344
  • 223. 42 C.F.R. § 486.346
  • 224. 42 C.F.R. § 486.348