Organ Transplant Programs

2060 - Organ Transplant Programs (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) 2060A – Citations (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) The Conditions of Participation (CoPs) for Transplant Programs were established under several statutory authorities. Section 1102 of the Social Security Act (the Act) authorizes the Secretary to publish rules and regulations “necessary for the efficient administration of the functions” with which the Secretary is charged under the Act. Section 1871(a) of the Act authorizes the Secretary to “prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title.” Section 1881(b)(1) of the Act contains specific authority for prescribing the health and safety requirements for facilities, including renal transplant programs, that furnish end stage renal disease (ESRD) care to beneficiaries. Section 1861(e)(9) of the Act authorizes developing standards necessary for the health and safety of individuals furnished services in hospitals. Organ transplant programs are required to be in compliance with the federal requirements set forth in the Medicare CoPs in order to be eligible to receive Medicare payment. In addition to meeting the CoPs for transplant programs in 42 CFR Part 482, Subpart E, transplant programs must also meet the Hospital CoPs specified in §§482.1 through 482.57. 2060B – DEFINITIONS (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) 2060B-1 Organ Procurement and Transplantation Network (OPTN) The OPTN is a public-private partnership that links all professionals involved in the donation and transplantation system. The OPTN operates the national network for organ procurement and allocation and works to promote organ donation. The OPTN was established by the National Organ Transplant Act of 1984 and is operated by United Network for Organ Sharing (UNOS) under a contract from the Health Resources and Services Administration (HRSA) in accordance with section 372 of the Public Health Service (PHS) Act. Through its policies, the OPTN works to increase the number of transplants, provide equity in access to transplants, improve outcomes for waitlisted patients, living donors, and transplant recipients, and promote living donor and transplant recipient safety. 2060B.2 Scientific Registry of Transplant Recipients (SRTR) The SRTR, founded in 1987, is a national database of transplant statistics that provides analytic support for the ongoing evaluation of the scientific and clinical status of solid organ transplantation in the United States. It was established pursuant to section 373 of the PHS Act. The SRTR produces Program-Specific Reports (PSR) to provide statistics on organ transplants. The reports contain information about candidates waiting for a transplant, outcomes on the waiting list, the transplant recipients, the donors, and the outcomes after a transplant. PSRs are produced twice each year for each organ transplant program (i.e., heart, intestine, kidney, liver, lung, and pancreas). More information on finding and comparing transplant programs can be obtained through the SRTR website at https://www.srtr.org/. More information on the PSRs can be found here: https://www.srtr.org/reports/program-specific-reports/ 2060B.3 United Network for Organ Sharing (UNOS) UNOS is a private, nonprofit membership organization that coordinates the nation’s transplant system under the OPTN federal contract. UNOS assists the transplant community and the patients it serves by: • maintaining the national organ transplant waiting list, • coordinating the matching and distribution of donated organs, • increasing public awareness of the need for donated organs, • serving as a forum to create and define organ-sharing policies that maximize the use of donated organs, • producing professional education tools, and • providing extensive information about organ transplantation to patients and the public. 2060C - Regulatory Background (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) The Conditions of Participation for transplant programs were published in the Federal Register on March 30, 2007 (72 FR 15198) and became effective 90 days after publication on June 28, 2007. For the first time, this final rule established Medicare Conditions of Participation for heart, intestine, kidney, liver, lung, and pancreas transplant centers. This rule set forth clear expectations for safe, high-quality transplant services delivered in Medicare-participating facilities. Effective July 16, 2012, the Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation final rule (77 FR 29034, May 16, 2012) revised the requirement at §482.92. This final rule eliminated a duplicative requirement for an organ recovery team that is working for the transplant center to conduct a ‘‘blood type and other vital data verification’’ before organ recovery when the recipient is known. The verification continued to be completed at two separate times in the transplant process. Effective July 11, 2014, the Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II rule (79 FR 27106, May 12, 2014) finalized changes to the transplant program Conditions of Participation. Specifically, it removed redundant data submission requirements and eliminated the automatic 3-year reapproval cycle. Thereafter, the Omnibus Burden Reduction Final Rule, published September 30, 2019 (84 FR 51732), removed the requirements at §482.82 that transplant programs must meet all data submission, clinical experience, and outcome requirements in order to obtain Medicare re-approval. This final rule became effective on November 29, 2019. Transplant programs are still required to comply with the CoPs at §§482.72 through 482.104 and the data submission, clinical experience, and outcome requirements for initial Medicare approval under §482.80.