Organ Transplant Candidacy and COVID-19 Vaccination Status

INSIGHTi

Organ Transplant Candidacy and COVID-19
Vaccination Status
February 4, 2022
A series of recent media reports have highlighted a current policy among at least some transplant centers
to deny potential transplant patients the ability to be waitlisted for an organ due to COVID-19 vaccination
status (see Business Insider, Washington Post, and Healthline). Transplant centers generally devise their
own policies and consider both medical and nonmedical criteria when selecting potential candidates to
add to the waitlist for an organ transplant (i.e., listing). Transplant centers can rule out a candidate when
transplantation is not considered the best treatment option for the particular patient. However, the larger
underlying issue in listing decisions is a lack of organ supply. The demand for organs far outweighs the
available supply. For instance, in 2020, 91,099 individuals were in need of a kidney, while 22,817 kidneys
were received. This lack of supply tends to be a key factor in the nationwide allocation of organs to
ensure that organs go to individuals with the most need and to individuals who will ensure optimal
stewardship of this scarce resource.
All transplant centers are members of the Organ Procurement and Transplantation Network (OPTN), a
program to coordinate organ allocation authorized by the National Organ Transplant Act of 1984 (NOTA;
P.L. 98-507, as amended) and administered through contract by the Department of Health and Human
Services (HHS), Health Resources and Services Administration (HRSA).
Multiple congressional committees have jurisdiction over the OPTN and oversee its activities. These
include House Energy and Commerce and Senate Health, Education, Labor, and Pensions. Other
committees also have jurisdiction over certain activities related to the OPTN, such as Senate Finance due
to the Centers for Medicare and Medicaid Services’ role in regulating members of the OPTN.
This Insight provides background information on the organ donation and transplantation system,
describes transplant center listing criteria, and outlines the current recommendations of relevant
professional organizations.
Background
Organ donations and transplantations are coordinated through the OPTN, a nationwide network of all
organizations (e.g., transplant centers, organ procurement organizations [OPOs], laboratories) involved in
the process. OPTN is administered by the United Network for Organ Sharing (UNOS), a private
Congressional Research Service
https://crsreports.congress.gov
IN11848
CRS INSIGHT
Prepared for Members and
Committees of Congress

---

Congressional Research Service
2
organization under contract with HRSA. UNOS has held the contract to administer OPTN since it was
established NOTA.
OPTN administers a series of policies intended to allocate organs with consideration of both the limited
number of organs and their short shelf-life, among other considerations. OPTN also issues white papers
that highlight a variety of topics for OPTN members, including ethical considerations.
OPTN Considerations for Transplant Candidacy
The OPTN does not issue policies requiring transplant centers to use specific criteria when determining
whether patients would be suitable candidates for transplantation. Nor does the OPTN require transplant
centers to have a specific selection process. The OPTN encourages transplant centers to develop their own
guidelines for transplant consideration, noting that each potential transplant candidate should be examined
individually and all guidelines should be applied without bias. The OPTN has noted that “listing
decisions are complex and that transplant clinicians try to work with patients to identify and mitigate risk
factors for negative outcomes and foster positive ones.”
In “General Considerations in Assessment for Transplant Candidacy,” OPTN explores a number of
nonmedical criteria that are commonly used by transplant programs in listing decisions. Two of those
criteria relevant to this topic are “potentially injurious behavior” and “adherence.” Potentially injurious
behavior may include nonadherence to medical recommendations among other behaviors. The adherence
criterion, in this context, is “understood to be a bi-directional, proactive process of discussion and
agreement between the patient and the medical team, on a course of therapy or management.” This
criterion specifically references the ability of the potential candidate to adhere to a medical regimen post-
transplant.
A refusal to adhere to medical recommendations pre-transplantation could be considered a potentially
injurious behavior. It could also provide insight into the potential candidate’s ability to adhere to post-
transplant medical regimens. OPTN maintains “that evaluation and listing decisions should be driven
primarily by medical benefit, and that potentially injurious behavior should not be considered a sole basis
for excluding transplant candidates unless [it] outweighs the benefit.” OPTN states in the white paper that
a history of consistent and documented treatment of nonadherence should be considered by the transplant
team.
Transplant Center Listing Criteria and Processes
Transplant centers do not have uniform selection criteria or processes nationwide. Policies vary by
transplant center. OPTN bylaws require all transplant centers to develop candidate selection procedures,
but provide no additional requirements for development of those procedures. According to a 2011 study
of liver transplant selection committees at four transplant centers, each transplant center conducted
weekly selection committee meetings to select candidates for listing. These meetings included transplant
coordinators, surgeons, hepatologists, and social workers. Other attendees varied depending on the
transplant center. For instance, some included ethicists, and some included experts in neuropsychology,
chemical dependence, and finance. In others, social workers assumed these roles.
Selection committees decide to list the patient, defer pending further review, or rule out. The 2011 study
found that justification for “rule out” decisions were as follows: (1) the patient was too well; (2)
comorbidities or advanced age; (3) the patient was too sick; (4) recent or active substance abuse; and (5)
other psychosocial barriers, including psychiatric disease, lack of or inadequate social support,
noncompliance or failure to complete testing, and inadequate insurance.

---

Congressional Research Service
3
Professional Organization Recommendations
The American Society of Transplant Surgeons (ASTS) has issued a position statement on the role of
COVID-19 vaccination for transplant candidates and recipients. In addition, the American Society of
Transplantation and the International Society for Heart and Lung Transplantation (AST and ISHLT,
respectively) issued a joint statement on the COVID-19 vaccine. Both statements recommend vaccination
against COVID-19 for transplant candidates. ASTS notes that this is consistent with their preexisting
“routine standards of care” to mitigate known infectious disease prior to organ transplantation. AST and
ISHLT specify that household and close contacts of the transplant recipient should also be vaccinated
when eligible and that all vaccination should occur prior to transplantation whenever possible.


Author Information

Jared S. Sussman

Analyst in Health Policy




Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff
to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of
Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of
information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role.
CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United
States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However,
as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the
permission of the copyright holder if you wish to copy or otherwise use copyrighted material.

IN11848 · VERSION 1 · NEW

---