Current Status of Proposals Submitted for Public Comment

Spring 2012

Proposed Changes to the Donation after Cardiac Death (DCD) Model Elements The proposed changes to the Donation after Cardiac Death (DCD) Model Elements will clarify and update language for the donation and transplantation community. These Model Elements identify specific requirements that OPOs and transplant centers must include in their DCD policies. As such, the name Model Elements has been changed to “Requirements.” DCD is redefined as Donation after Circulatory Death (DCD) in order to accurately reflect the definition of death determined by cardio-pulmonary criteria. The OPO Committee has also added the following language that mirrors the Centers for Medicare & Medicaid Services (CMS) requirements: 1) OPOs and transplant centers must establish protocols that define the roles and responsibilities of the OPO and the transplant center for all activities associated with the DCD donor and 2) OPOs must have a written agreement with Medicare and Medicaid participating hospitals and critical access hospitals in its service area that describes the responsibilities of both the OPO and hospital concerning DCD. Additionally, other policies using the term “Donation after Cardiac Death" will be modified for consistency. These proposed changes will help provide a common understanding of DCD protocols for the transplant community and the public. This proposal was approved at the November 2013 Board of Directors Meeting.

Proposal to Require Extra Vessel(s) Disposition to be Reported to the OPTN within Five Days of Transplant or Disposal The proposed policy language within section 5.10.2 (Vessel Storage) will require centers to report disposition of extra vessels to the OPTN within five days of transplant or disposal. Five working days was identified as a good option for this requirement because donor feedback is required within five days and the proposed timeframe allows for validation of data. Transmission of infectious diseases through organ transplantation is a patient safety issue and can be a significant public health concern. Disease transmission via the use of deceased or living donor organs and extra vessels can result in serious illness or death in recipients. The proposed changes would provide the OPTN with appropriate information on the use of extra vessels soon after they are transplanted and disposed of to assist in communicating information about potential disease transmissions when reported for the extra vessel(s) donor. The proposal was approved during the November 2012 OPTN/UNOS Board of Directors Meeting. The policy change is pending programming.

Proposal to Revise the Lung Allocation Score System The Thoracic Committee proposes a revision to the Lung Allocation Score (LAS) system. This revision includes modifications to the covariates in the waiting list and post-transplant survival models, coefficients of the covariates, and the baseline waiting list and post-transplant survival rates. The Committee intended for the LAS system to be dynamic to address disease severity and post-transplant survival for a given current candidate population. Except for the addition of partial pressure of carbon dioxide (PCO2) as a covariate to the LAS system’s waiting list model, a thorough revision of the LAS system has not occurred since its implementation. The proposed revisions to the LAS update the system to enable prioritization of candidates using data derived from a population transplanted due to their LAS’s, instead of their waiting time. The proposal was approved during the November 2012 OPTN/UNOS Board of Directors Meeting. The policy change is pending programming. Fall 2012

Proposal to Remove the OPTN Bylaw for the Combined Heart-Lung Transplant Program Designation The proposed change removes an OPTN bylaw for designating a single combined heart-lung transplant program. There are no such bylaws for designating other single combined organ transplant programs. A combined heart-lung transplant program must concurrently have both an approved heart transplant program and an approved lung transplant program. The requirement needlessly burdens the transplant hospital to obtain approval for an additional organ transplant program designation to transplant organs for which the transplant hospital has already been approved. Aside from submitting often duplicative key personnel information, there are no additional requirements a transplant program must meet in order to qualify for the designation. The combined heart-lung transplant program designation also creates unnecessary programming work for the OPTN Contractor. The region approved this proposal without comment. This proposal was approved by the Board during the June 2013 meeting and was effective on September 1, 2013.

Proposal to Change the OPTN/UNOS Bylaws to Better Define Notification Requirements for Periods of Functional Inactivity The purpose of this proposal is to better define the notification requirements for periods of functional inactivity. Currently, the Bylaws do not clearly outline the actions a Member must take when it becomes functionally inactive. This Bylaw proposal clarifies the current notification requirements for functional inactivity by including specific requirements for notification of functional inactivity, including waiting list inactivation in UNetsm. These modifications also specify what a member must do in terms of notifying patients when a program voluntarily ceases performing a specific type of transplant. The region approved this proposal without comment. This proposal was approved by the Board during the June 2013 meeting and was effective on September 1, 2013.

Proposal to Substantially Revise the National Kidney Allocation System This proposal seeks to substantially revise the national kidney allocation system by incorporating new features such as an expanded definition of waiting time, a sliding scale for assigning points to sensitized patients, expanded access for blood group B candidates who can accept A2 or A2B kidneys, broader sharing for extremely highly sensitized candidates, longevity matching of some kidneys, and regional sharing for kidneys with the highest risk of discard. The proposed changes are estimated to result in an additional 8,380 life years achieved annually from the current pool of deceased donor kidneys while improving access for sensitized candidates and minority candidates. The region approved this proposal with comment to the committee. Committee Response: The Committee appreciates the comment and agrees that comprehensive educational materials are needed for both patients and transplant professionals to stress the importance of early referral. The Committee has formed an education subcommittee which will work closely with UNOS Instructional Innovations and UNOS Communications to develop and deliver these materials in a variety of formats. Additionally, the Committee has modified the proposal to no longer require titer values for A2/A2B candidates. The Committee recognizes the request to provide blood type O candidates with priority for kidneys from blood type A2/A2B donors. In the proposal, only candidates with blood type B who meet certain titer requirements receive priority for kidneys from these donors. During its January 2013 conference call, the Committee was reminded that the A2/A2B priority was designed as a committee sponsored alternative system by the Minority Affairs Committee. The purpose of the system, as designed, was to reduce disparities faced by minority candidates. The Committee reviewed the relationship between blood type and ethnicity. As of January 4, 2013, 34.5% of 49,679 candidates with O blood type were African American while 45.6% of 15,188 candidates with B blood type were African American. Additionally, Wida Cherikh, PhD, UNOS Biostatistician shared that the ability of a candidate to meet the titer requirements is linked to blood type. Data from the Midwest Transplant Network OPO showed that of 109 B candidates who have had at least one year of anti-A titer history (at least 4 quarterly anti-A titers performed), 75% (82/109) had consistently low titers. By contrast, of 235 O candidates who have had at least one year of titers done, only 31% consistently had low anti-A titers. Thus, the likelihood of finding a patient with a consistently low anti-A titer history is much greater for B candidates than O candidates. Furthermore, no significant difference existed between African American and Caucasian B candidates with respect to the incidence of candidates with a consistently low anti-A titer history. In Caucasian candidates, 77% (54/70) had a low titer profile compared with 69% (24/35) of African American patients who have a low anti-A titer history. In light of this additional data, the Committee decided not to modify this portion of the proposal. This proposal was approved by the Board during the June 2013 meeting and will be effective pending programming. Implementation will be completed in two stages with the first phase in mid June 2014 (data collection and verification) with an estimated completion date of Dec 2014. Additional information about training and implementation plans will be distributed in the spring of 2014.

Proposal to Change the Composition of the OPTN Finance Committee This proposal recommends changing the composition of the OPTN Finance Committee so that it solely consists of members of the OPTN Board of Directors. Currently, the OPTN Finance Committee is a constituent committee with regional and at-large appointments, and it reports to the OPTN Board of Directors. For most organizations, financial governance begins with a finance committee that resides at the board level. To improve the efficient management of the OPTN, the proposal is recommending changing the Finance Committee from a constituent committee that reports to the Board, to one that is an arm of the Board, and exclusively composed of its members. This change is expected to better align the OPTN’s operational and financial decision making processes. The region approved the proposal with comment. Regional Comment: The region is concerned that the proposal does not provide enough detail as to how the individuals from the board will be selected to serve on this committee. They feel strongly that since this proposal dissolves the current structure of regional representation there should be defined publicly available criteria for how individuals will be elected to serve. The region would like to see additional explanation regarding the legal parameters of a board committee included in a preamble to this section or provided as reference materials. The region was unclear as to the authority of these committees and who can serve with the information provided in proposal. This proposal was submitted to the Board for consideration in June 2013 and was approved. The change was implemented on September 1, 2013.

Proposal to Require Reporting of Every Islet Infusion to the OPTN Contractor within 24 Hours of the Infusion The goal of this proposal is to require the accurate and timely reporting of every islet infusion to the OPTN Contractor and to update language in policies and bylaws to reflect current practice for reporting islet infusions and outcomes information. Currently, islet Transplant Programs are not required to report every islet infusion to the OPTN Contractor. Therefore, it is possible that the OPTN Contractor may be unaware which islet recipients have received infusions, which could have implications for patient safety or disease transmission. This proposal: 1. Requires islet programs to report each islet infusion to the OPTN Contractor within 24 hours of the infusion, while still allowing islet candidates to retain their waiting time through three consecutive islet infusions. 2. Removes outdated requirements in the bylaws for submitting islet logs. 3. Adds language in the bylaws to reflect current programming for when an additional registration fee is generated after an islet candidate is removed from the waiting list for transplant and immediately re-registered for another infusion. The region approved this proposal with comment. Region 7 Comments: The region approved this proposal but strongly urged UNOS to conduct a review of the current reporting and notification system to identify ways to streamline the proposed process. The region is in complete support of any changes that enhance patient safety but felt that there should be a more efficient way to carry out this change that did not involved having to notify patients with 3 listing and 3 delisting letters. Committee response: The Committee appreciates Region 7’s consideration of this proposal and its feedback. Regarding the workload and operational impact of these policy changes, policy specifies that transplant centers are not required to notify the patient each time they are removed from the waiting list upon receiving an islet infusion. However, the Committee believes it is reasonable for transplant centers to notify the candidate about each additional relisting, as is currently required for each whole organ registration. At most, this policy change would require two additional notifications. This proposal was submitted to the Board for consideration in June 2013 and was approved. Implementation is scheduled for Fall 2014.

Proposal to Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions The proposed changes clarify the data collection definitions for determining whether a death can be classified as “imminent” or “eligible.” OPOs must classify a death as one of the following: Imminent Neurologic Death (“imminent”), Eligible Death (“eligible”), or neither “eligible” nor “imminent” (“neither”). The OPOs then report the “imminent” and “eligible” deaths to the OPTN. Because OPOs interpret reporting definitions differently and because brain death laws vary from state to state, OPOs are inconsistent in the way they report death data. The changes proposed by the Committee eliminate multi-system organ failure (MSOF) as an exclusionary criterion for classifying a death as “eligible” and add a list of organ-specific exclusionary criteria to give OPOs more guidance. The Committee also changed the definition of “imminent” to restrict it to those deaths that would most likely be classified as “eligible” had brain death been legally declared. This change could allow the combination of “eligible” and “imminent” deaths to mitigate the effect of the variation in brain death laws. The region approved this proposal with comment. Regional Comments: The region supports the committee in their undertaking of redefining these definitions and feels that this is a step in the right direction but they are very concerned about the method used to develop the eligible criteria. Specifically because several of the proposed parameters are currently outside of local acceptance practices. The region encourages the OPO committee to work with OPOs or regions who are currently undertaking true potential pilot programs to see if these critieria are reasonable. Additionally, the region was adverse to one of the rule out parameters being that the OPO has to go to the OR. The region feels strongly that the OPTN should be able to develop a “stop point” using statistical analayst of organ specific math runs for when an offer becomes futile and at that point, the organ should be considered not eligible. Not incorporated into the final proposal. Committee response: The OPO Committee appreciates these comments. Each of the organ specific imminent and eligible death criteria were established by OPTN organ specific committees made up of representatives of all of the Regions. Each of the organ specific committees, and the OPO Committee, are in agreement on each organ’s imminent and eligible death definition criteria. Where a specific metric appears in the proposed criteria, such as BMI, minimum body weight, age, etc., a three year cohort of data from donors yielding at least one organ for transplant was used to identify the 99th percentile for each specific metric. The proposed definition is uniform for OPO reporting of imminent and eligible deaths within a given DSA, and not developed to affect OPO efforts to procure organs from donors outside of the definition, nor to influence transplant center acceptance practices. This proposal was submitted for Board consideration in June 2013. The Board approved the proposal but delayed implementation until December 1, 2013 to provide time for work with CMS. At the November 2013 Board meeting, the implementation was pushed back to January 1, 2015 to allow CMS additional time to align its definitions with the OPTN definitions.