Transplant center / hospital

A transplant center (also called a transplant program or transplant hospital) is a hospital that performs solid-organ transplantation and, in the United States, holds Medicare approval to do so for one or more specific organ types.[1][2] Transplant approval is granted on an organ-specific basis: a hospital may be approved to run, for example, a kidney program and a liver program independently, each of which must separately satisfy federal requirements.[1] Under U.S. law a transplant program is regulated principally through the Medicare Conditions of Participation at 42 CFR Part 482 Subpart E and, in parallel, through membership in the Organ Procurement and Transplantation Network (OPTN) under the OPTN Final Rule (42 CFR Part 121).[1][3]

This article describes what a transplant center is, the federal Conditions of Participation that govern it, the history of those rules, and its relationships to the OPTN, organ procurement organizations, and public outcome reporting.

Definition and scope

A transplant center is a unit within a Medicare-participating hospital that evaluates candidates, places them on the national waiting list, performs transplant surgery, and manages recipients and living donors.[1] CMS approval covers the organ types named in the regulation: heart, heart-lung, intestine, kidney, liver, lung, and pancreas programs.[1] A program located within a hospital that has a Medicare provider agreement must meet the Conditions of Participation at 42 CFR §§482.72 through 482.104, in addition to the general hospital Conditions of Participation at §§482.1 through 482.57 (except §482.15), in order to be approved by CMS to furnish transplant services.[1]

Transplant centers are distinct from organ procurement organizations (OPOs), the nonprofit entities responsible for deceased-donor recovery in a defined service area; the two interact across the donation pathway, with the OPO recovering and offering organs and the transplant center accepting and implanting them.

CMS Conditions of Participation (42 CFR Part 482 Subpart E)

The Conditions of Participation for transplant programs were established as a discrete subpart of the hospital Conditions of Participation. Key provisions include:[1]

• Designation and general requirements (§§482.68-482.76). A hospital must be approved by CMS as a transplant program to provide transplant services; the subpart applies to the listed organ-specific programs, with special provisions for pediatric transplants.[1]
• Data submission, clinical experience, and outcome requirements (§482.80). For initial approval, a program must submit to the OPTN at least 95 percent of required data on all transplants it performs (deceased- and living-donor) within 90 days of the OPTN due date.[4] CMS evaluates one-year post-transplant outcomes by comparing the program's observed number of patient deaths and graft failures against its expected number, using the most recent Scientific Registry of Transplant Recipients (SRTR) program-specific report.[4] Under the regulation, survival is deemed below standard only when all three of the following are met: a one-sided p-value below 0.05, observed events exceeding expected by more than 3, and an observed-to-expected ratio above 1.85.[4]
• Process requirements (§§482.90-482.96). These cover patient and living-donor selection, organ recovery and receipt, patient and living-donor management, and a transplant-program quality assessment and performance improvement (QAPI) program (§482.96) that must track outcomes and adverse events.[1]
• Patient and living-donor rights (§482.102). Programs must give prospective living donors written information on the evaluation and surgical procedures, medical and psychosocial risks, insurance implications, national and program-specific outcomes, and the donor's right to opt out of donation at any time; communications between donor and program are confidential.[5] Transplant candidates must be informed of evaluation and surgical risks, alternative treatments, program-specific and national outcome data, and their right to refuse transplantation.[5]
• Human resources and director qualifications. The subpart requires each program to identify a qualified transplant surgeon and transplant physician and to provide other specified personnel.[1]

The Conditions of Participation also require that a program use an Independent Living Donor Advocate (ILDA), a person or team, not involved in the recipient's care, charged with protecting the living donor's interests and informed consent, for living-donor programs.[1][6] The ILDA requirement is reinforced by OPTN policy.[6]

History of the Conditions of Participation

CMS finalized the transplant-center Conditions of Participation in a March 30, 2007 final rule, which for the first time set uniform, organ-specific data, clinical-experience, and outcome requirements for both initial approval and re-approval of Medicare transplant programs.[7] Under that framework, programs whose one-year outcomes fell below the statistical thresholds could face loss of Medicare approval unless they qualified for a "mitigating factors" review.[7]

In a final rule published September 30, 2019 ("Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction," effective November 29, 2019), CMS *eliminated the data, clinical-experience, and outcome requirements for re-approval** of transplant programs.[8] CMS reasoned that the re-approval outcome thresholds had created pressure on programs to avoid higher-risk transplants, contributing to organ non-use and fewer transplants, and that removing them would increase transplant opportunities and organ utilization.[8] The outcome and data requirements at §482.80 were retained for initial approval*, and programs that fall short may still seek a mitigating-factors review under 42 CFR §488.61.[4][8] (This division, initial-approval thresholds retained, re-approval thresholds removed, should be re-verified against current CMS guidance, as the agency has continued to issue survey-and-certification guidance on transplant programs.)

Relationship to OPTN membership and the OPTN Final Rule

A transplant program must also be a member in good standing of the OPTN. Under the OPTN Final Rule (42 CFR Part 121), the three OPTN membership categories are transplant hospitals participating in Medicare or Medicaid, all OPOs, and other interested organizations and individuals (including non-Medicare transplant hospitals).[3] To receive organs for transplantation, a designated transplant program in an OPTN-member hospital must, among other things, be a transplant program approved by the Secretary for reimbursement under Medicare, or be a Department of Veterans Affairs, Department of Defense, or other federal hospital program (42 CFR §121.9).[3] A program that remains non-compliant after OPTN due process may be deemed a "Member Not in Good Standing" by the OPTN Board.[3] Membership and the federal Conditions of Participation thus operate as parallel, mutually reinforcing systems of oversight, both ultimately grounded in the National Organ Transplant Act (NOTA).

Relationship to OPOs and the duty to notify

Deceased-donor organs reach transplant centers through OPOs. Hospitals are federally required (42 CFR §482.45) to notify their OPO of every imminent death and death, so the OPO can evaluate donation potential; recovered organs are then allocated through the OPTN match run and offered to candidates at transplant centers.[9] A transplant center's acceptance practices, including its willingness to use higher-risk organs, are tracked through the OPTN and SRTR.

SRTR program-specific reports and public reporting

The SRTR publishes program-specific reports (PSRs) for every transplant program, including risk-adjusted one-year patient and graft survival, transplant rates, and waitlist outcomes; these reports are the data source CMS uses for the §482.80 outcome comparison and are published for patients and the public.[4][10] Public availability of program-level outcomes is intended to support patient choice and program accountability, though commentators have noted that outcome-based oversight can create incentives that affect organ acceptance.[8][10]

Oversight

CMS approves and oversees transplant programs through its survey-and-certification process, conducted by CMS regional offices and state survey agencies, with periodic on-site surveys and validation against the Conditions of Participation.[2] A program that loses Medicare approval cannot bill Medicare for transplant services and generally cannot remain an OPTN member in good standing, the combined effect of which is loss of the program. Oversight thus rests on three interlocking pillars: the CMS Conditions of Participation, OPTN membership and policy, and SRTR public outcome reporting.[2][3][10]

See also

• The donation pathway
• National Organ Transplant Act (NOTA)
• Histocompatibility (HLA) laboratory
• Organ transplantation

References

• 42 CFR Part 482 Subpart E, Requirements for Specialty Hospitals (transplant centers). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-E
• Centers for Medicare & Medicaid Services. Organ Transplant Program (certification & compliance). https://www.cms.gov/medicare/health-safety-standards/certification-compliance/organ-transplant-program
• 42 CFR Part 121, Organ Procurement and Transplantation Network (OPTN Final Rule); §121.9 Designated transplant program requirements. https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121
• 42 CFR §482.80, Data submission, clinical experience, and outcome requirements for initial approval of transplant programs. https://www.law.cornell.edu/cfr/text/42/482.80
• 42 CFR §482.102, Condition of participation: Patient and living donor rights. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-E/subject-group-ECFRc4be2badf376a95/section-482.102
• Organ Procurement and Transplantation Network. Guidance for the informed consent of living donors (Independent Living Donor Advocate). https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/guidance-for-the-informed-consent-of-living-donors/
• Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants. 72 Fed. Reg. 15198 (Mar. 30, 2007). https://www.federalregister.gov/documents/2007/03/30/07-1435/medicare-program-hospital-conditions-of-participation-requirements-for-approval-and-re-approval-of
• American Society of Transplant Surgeons. CMS Removes Outcomes Requirement for Transplant Center Re-approval (Sept. 27, 2019); Medicare Program; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction final rule (Sept. 30, 2019; eff. Nov. 29, 2019). https://www.asts.org/connect/news/2019/09/27/cms-removes-outcomes-requirement-for-transplant-center-re-approval
• 42 CFR §482.45, Condition of participation: Organ, tissue, and eye procurement (duty to notify the OPO). https://www.law.cornell.edu/cfr/text/42/482.45
• Scientific Registry of Transplant Recipients. Program-specific reports. https://www.srtr.org/