policy
timeline of policy development

Kidney and pancreas policy development updates

New policy adopted to improve kidney, pancreas distribution; Effective placement of liver matches, HOPE Act extension also addressed

Dec. 5, 2019—Dallas – The Board of Directors of the Organ Procurement and Transplantation Network, at its meeting Dec. 3, approved a new system for matching kidney and pancreas transplant candidates with organs from deceased organ donors. The new policy establishes new distribution areas based on the donor location and is projected to increase equity in transplant access for candidates regardless of where they live or list for a transplant.

“The local and regional boundaries we have used for decades often do not reflect the practical and clinical needs of transplant candidates based on how near or far they are to an organ donor,” said Maryl Johnson, M.D., board president. “The new system is better at addressing distance as a factor in transplant matching. It’s also in keeping with our mandate to make sure that objective medical factors, not geography, should be the key to matching donors and recipients.”

New geographic area for offers; additional priority for candidates closer to donor location

Under the newly approved system, expected to be implemented in 2020, kidney and pancreas offers (except for rare, very well-matched donor and recipient combinations nationwide) will be offered first to candidates listed at transplant hospitals within 250 nautical miles of the donor hospital. Offers not accepted for any of these candidates will then be made for candidates beyond the 250 nautical mile distance.

Candidates also will receive proximity points based on the distance between their transplant program and the donor hospital. Proximity points are intended to improve the efficiency of organ placement by adding priority for candidates closer to the donor hospital. Candidates within the initial 250 nautical mile radius will receive a maximum of two proximity points, while those outside the initial circle will receive a maximum of four proximity points. The point assignment will be highest for those closest to the donor hospital and will decrease as the distance increases.

Differences from current system and predicted benefits

The new system will replace a three-tiered approach used since the beginning of national organ allocation policies in the mid-1980s. Currently, most kidney and pancreas offers go first to candidates listed at hospitals within the same donation service area (DSA) where the donor hospital is located. There are 58 DSAs reflecting the assigned service area of organ procurement organizations (OPOs). These DSAs are fixed, often irregular geographic boundaries, and were not set for the express purpose of optimizing organ allocation. In some instances, portions of the same DSA are not contiguous, meaning that some “local” donor matches may travel through service areas belonging to other OPOs.

Organ offers not accepted at the DSA level currently are made to candidates at hospitals within the same OPTN region as the donor hospital. Finally, offers not accepted at the DSA or regional level are made to candidates listed at transplant programs anywhere else in the United States.

“Under the current system, candidates listed at two different hospitals just a short distance apart from each other, and a short distance from a donor hospital, can appear much higher or lower on a match just because their hospitals are in different DSAs or regions,” Johnson said. “The new policy will remove those artificial distinctions for candidates who are much the same as each other in terms of distance and medical need.” In addition, statistical modeling indicates the policy will increase transplant access for key groups of transplant candidates, including children, women, ethnic minorities and those who are hard to match with many donor offers due to high immune sensitivity.

New procedure to improve liver placement

In other action, the OPTN board approved a policy change to allow more efficient placement of donated livers when a transplant program first accepts a donor offer and then rescinds it late in the recovery process. The update allows livers affected by such late refusals to be offered to transplant programs that opt to be contacted for such offers and that provide specific information in advance regarding the types of offers they would be willing to accept. Making subsequent liver offers first to transplant programs willing to consider them is expected to place the offers more quickly and increase the chance that the liver will be transplanted.

HOPE Act provisions extended

The board also approved a change to the expiration date of the OPTN policy variance supporting the federal HIV Organ Policy Equity Act (HOPE Act).  Under the HOPE Act, research is underway to assess the effects of transplantation of organs from donors with HIV to candidates with HIV.  The expiration date of the variance has been extended to January 1, 2022, to allow a more robust review of the results of the study.

Other actions

The board took additional actions as follows:

  • Approved a slate of nominees for election to open positions on the board in July 2020
  • Accepted clarifications to OPTN data submission and release policies
  • Amended the process for selection of the Vice Chair of the OPTN Histocompatibility Committee
  • Accepted updates to align units of distribution for a closed split liver variance
  • Approved a policy clarifying the definition of pre-existing liver disease
  • Approved updates to OPTN committee charters
  • Terminated select allocation variances that are no longer applicable or no longer in use
  • Approved changes to tables listing histocompatibility antigens and equivalents in OPTN policy
  • Referred a list of project ideas to the OPTN Policy Oversight Committee to prioritize with the goal of increasing organ utilization through efficient donor/recipient matching

Revised proposals for replacement of DSA and Region will be presented to the OPTN Board of Directors at its Dec. 3, 2019 meeting; committee briefing papers now available

Nov.26, 2019 —Revised proposals for replacement of Donation Service Area (DSA) and Region as distribution units in kidney and pancreas allocation policy will be presented to the OPTN Board of Directors at its Dec. 3, 2019 meeting. 

The Kidney and Pancreas Transplantation Committees’ briefing papers for the Board are now available. These reports contain the proposal language the committees will bring to the Board of Directors and offer an evaluation of key factors as well as an overview of community feedback and committee response.

The sponsoring committees removed language from both proposals regarding import backup, in favor of additional discussion and input.  In addition, the Kidney Transplantation Committee removed the provision regarding candidate medical urgency for additional consideration and input.  Those proposals, as well as a proposal to treat Alaska donors as if they are located at the Sea-Tac airport for the purposes of allocation, will be released for public comment in January 2020.  Workgroups have been formed to focus on import backup and medical urgency.  They are working diligently to prepare the proposals.

Summaries of the October in-person meetings are also now posted on the committee pages.

Additional information and resources are available here on the OPTN website. 

 

 

Kidney and pancreas allocation proposals modified, import backup workgroup and medical urgency subcommittee formed

Nov.18, 2019 —The Organ Procurement and Transplantation Network’s Kidney Transplantation and Pancreas Transplantation Committees have made key modifications to proposals to replace donation service area (DSA) and region as distribution units in kidney and pancreas allocation policy.  These updates reflect major themes identified in public comment and additional committee discussion of potential effects of various policy options. These proposals will be presented to the OPTN Board of Directors at its meeting December 3, 2019.

The key actions as recommended by the committees after public comment include:

  • Reduction of the circle size from a radius of 500 nautical miles to 250 nautical miles
  • Import backup language removed from kidney and pancreas proposals for additional evaluation
  • Medical urgency status removed from the kidney proposal for additional evaluation

Reduction in circle size

Key changes include reduction of the local allocation circle size to a 250 nautical mile radius, as well as reduction of proposed proximity points (a maximum of two points for candidates at transplant programs within the circle and a maximum of four points for candidates listed outside the circle). 

Import backup and medical urgency

When they met in October, the committees concluded that additional study and discussion is needed before deciding on the import backup procedure for kidney and pancreas offers, as well as the criteria to determine medical urgency for kidney candidates.  As a result, these elements will not be part of the proposals brought for action by the OPTN Board of Directors December 3.  The committees will seek additional public comment on these elements, with the intent of including them in implementation alongside the final policies approved by the board.

A workgroup has been formed to address import backup, including members of the Kidney, Pancreas, OPO, Histocompatibility, and Operations and Safety Committees. They will meet weekly for the next month to determine a practical solution to the reallocation of kidneys and pancreata once DSA is removed from allocation. To address kidney candidate medical urgency, a subcommittee of the Kidney committee will also be meeting weekly over the next month to define medical urgency criteria for kidney transplant candidates and determine how this should be operationalized.

The workgroup and subcommittee intend to have criteria ready for supplemental proposals in the Spring 2020 public comment period.  Each of the provisions to be presented in supplemental public comment proposals is intended to be incorporated into the kidney and pancreas policies set for approval at the Dec. 3 meeting.  The deliberations about these supplemental proposals will include considerations of implementation timing and complexity, with the intent to deliver proposals that can be implemented simultaneously with the removal of DSA and region policies.

Find updates and additional kidney and pancreas resources here.

 

Kidney and pancreas allocation proposals modified

Oct. 28, 2019 — The OPTN Kidney Transplantation and Pancreas Transplantation Committees, following consideration of extensive public comment, will advance updated allocation proposals to the OPTN Board of Directors for consideration at its December 3 meeting. The proposals eliminate donation service area (DSA) and region from policy and replace them with a system that allocates kidneys and pancreata based on distance between the hospital listing the transplant candidate and the donor hospital.

Statistical modeling suggests the proposed changes will reduce variation in the amount of time candidates wait for kidney transplants in various areas of the country.  The proposed policies should also increase transplant rates for key groups of candidates including ethnic minorities, children, and those who are difficult to match due to high immune sensitivity.

Under each proposal, after a kidney and/or pancreas is offered for any exceptionally well-matched donor-candidate combination nationwide, the next candidates to receive offers are those listed at hospitals within 250 nautical miles from the donor hospital. Offers not accepted for any of these candidates would then be made for those at hospitals beyond a 250 nautical mile radius.

This represents a change from proposals both committees circulated for public comment in August 2019. The committees studied various alternative circle sizes, including the 250 nautical mile radius, and simulation modeling suggested each option would improve upon current allocation based on key metrics. While the two committees initially recommended circles of 500 nautical miles, a substantial theme in public comment was that the wider proposed circle would pose major logistical challenges for organ acceptance and transportation.

“We appreciate the input of everyone who commented on the proposal,” said Vincent Casingal, M.D., chair of the Kidney Committee. “There was a range of views, but many were concerned about unwanted effects we might see with a 500 nautical mile approach. The 250 nautical mile radius is more consistent with established logistics while also replacing the current local and regional boundaries with a more consistent framework nationwide.”

Also under the proposals, transplant candidates would receive proximity points based on the distance between their transplant program and the donor hospital. Proximity points are intended to improve the efficiency of organ placement by adding priority for candidates closer to the donor hospital. Doing so can minimize organ preservation time and increase the likelihood of organ function.

As proposed, candidates within the initial 250 nautical mile radius would receive a maximum of two proximity points, while those outside the initial circle would receive a maximum of four proximity points. At each level, the points would be highest for those closest to the donor hospital and would decrease as the distance grows between the donor and transplant hospitals.

The proximity points in the revised proposals also decreased from those in the public comment proposals (as many as four for candidates in the initial circle and eight for those outside the circle). “With a smaller distribution circle, logistical challenges become less of a factor,” said Silke Niederhaus, M.D., chair of the Pancreas Committee.

The committees will present their updated proposals for action by the OPTN Board of Directors at its meeting December 3, 2019, in Dallas. Additional clarifying policy components will be circulated for additional public comment early in 2020 and implemented along with the policies as approved by the board. The additional components include classifying medical urgency for kidney candidates and providing for backup offers when a kidney or pancreas cannot be used for the first intended candidate.

Committees to review kidney and pancreas proposals

Oct. 18, 2019 — Thank you to everyone who submitted public comment on the OPTN Kidney Transplantation and Pancreas Transplantation Committees’ proposals to remove Donation Service Area (DSA) and OPTN Regional boundaries from allocation policies. From August 2 to October 2, the OPTN received numerous comments on the two proposals. All comments received are posted on the public comment section of the OPTN website.

The Kidney Committee will meet in-person on Monday, October 21 and the Pancreas Committee on Wednesday, October 23. To prepare for their in-person meetings, both committees met separately via conference call to review public comments and provide committee members with an opportunity to ask questions.

During their respective in-person meetings, the committees will have in-depth discussions to evaluate all public comments and decide next steps for the proposals. We will keep you informed as to whether the committees continue with the proposals as submitted for public comment or make changes based on public comment feedback.

If you have questions about either proposal, please contact the following staff:

Transplant patient webinar addresses proposed changes to kidney and pancreas distribution

Sept. 16, 2019 — Transplant candidates, recipients and their families have a unique perspective on national organ transplant policy. UNOS, in its role as the national Organ Procurement and Transplantation Committee (OPTN), encourages all who are interested to read and offer public comment on proposed policies.

Two proposals recently out for public comment seek to eliminate geographic boundaries currently used in kidney and pancreas allocation. The proposed policies would replace local donation service area (DSA) and regional boundaries with a 500 nautical mile circle around the donor hospital. After the organ is offered to all eligible candidates listed inside the 500 nautical mile circle, it would then be offered to eligible candidates beyond 500 nautical miles.

The OPTN kidney and pancreas transplantation committees hosted a webinar on September 16, 2019, to describe the proposals for transplant patients and family members.

View the presentation.

Kidney and pancreas distribution modeling analysis

Aug. 7, 2019 — The goals of removing donation service area (DSA) and region from kidney and pancreas distribution are to create more equity in access to transplantation for candidates regardless of where they live, and to ensure that these allocation policies meet the requirements of the OPTN Final Rule. Under current allocation, research performed by the OPTN highlights the candidates’ place of residence or listing as the largest factor related to disparity in kidney allocation1.

The OPTN kidney and pancreas transplantation committees both have worked to identify alternatives to DSA and region that improve overall equity in geographic distribution. This effort does not affect other important allocation factors, such as keeping the elevated priority for highly sensitized patients. The goal of this project is to revise the role of geography for kidney, pancreas and combined kidney-pancreas transplants.  Work related to multi-organ priority is out of scope and will be addressed in a future, cross-organ policy project.

Alongside committee clinical and professional experience, the SRTR Kidney-Pancreas Simulation Allocation Model (KPSAM) is an important tool that OPTN committees use when developing changes to organ allocation policy.  The latest SRTR report models proposed replacements of current DSA and region boundaries in kidney and pancreas allocation with single-circle allocation systems of 150, 250, or 500 nautical miles (read about the different modeling input on page 3 of the full report).  Any organs not accepted inside the first circle of allocation would be offered at the national level.

Below are some takeaways from the latest modeling:

  • Nearly all scenarios yielded similar results in terms of effects on subpopulations.
  • Kidney transplant rates remained nearly constant under broader distribution:
    • Rates among pediatric, female, African American, and Latino candidates increased.
    • Rates among highly sensitized (80-99% cPRA) and high dialysis time (> 5 years) candidates increased.
  • Slight decreases were noted in transplant rates for non-metropolitan candidates and no change in percentage of kidney alone transplants. Modeling indicates that candidates in rural areas would have similar rates of transplant compared to candidates in cities.
  • The larger the circle is, the farther distance organs would travel.  This may lead to increased cost and logistic issues for which there is only anecdotal evidence to examine.
  • Kidney-pancreas transplant rates increased across all broader distribution scenarios modeled:
    • In general, the kidney-pancreas transplant rate increased as the circle size increased.
    • Percentages of transplants among African American, and females increased.
    • Rates among highly sensitized (80-98% cPRA) candidates increased.
    • As the pancreas circle size increases, KP transplant counts increased, leading to subsequent decreases in kidney and pancreas alone transplants. This is due to the absolute priority KP candidates are given over kidney and pancreas alone candidates at the current local level.
  • Although the model predicts that pancreas alone transplant rates decrease across each scenario, the Committee notes that the model does not reflect individual program behavior.

Overall:

  • While there was a projected decrease in kidney alone and pancreas alone transplants, when examining the total number of kidney transplants (kidney alone and KP), the total number of transplants varied little across model variations, and almost no change was seen from baseline.
  • As expected, the decrease in kidney alone, and simultaneous increase in kidney-pancreas, saw the largest change in the biggest circles (e.g. 500 NM) and change was minimized in the smaller circles (e.g. 150 NM).
  • Proximity points are considered being added to current candidate characteristics that currently receive points, such as candidate CPRA or ABDR-mismatching in kidney allocation, to weight proximity to the donor in matching potential transplant recipients to deceased donor organs. Higher values of proximity points would indicate that a larger weight, or value, is placed on geography; candidates closer to the donor in proximity would receive more proximity points than candidates further away. It’s also important to note that candidates cannot move from outside the circle to inside the circle, regardless of how many proximity points are assigned.  The function of proximity points is addressed in a prior concept paper.
  • KPSAM results showed that proximity points were successful in reducing travel of the organ inside the circle, but were less impactful in national allocation. However, a relatively small number of organs (10-20 percent) are predicted to occur nationally, which may be an under prediction. Given the limitations of the KPSAM, there is likely a larger number of transplants occurring from acceptances further down the match than sequence #200 that aren’t accounted for in the results due to computational and other modeling limitations.

It is important to note that modeling cannot account for changes in organ acceptance behavior or identify trends over time, and that the output would not reflect instances of transplants for organs accepted past 200 in the sequence of offers.

If you have any questions about the next steps for changing these policies or about the modeling, please contact Scott Castro (scott.castro@unos.org) or Amber Wilk (amber.wilk@unos.org) for kidney questions and Abby Fox (abigail.fox@unos.org) or Read Urban (read.urban@unos.org) for pancreas questions.

Defined Terms

cPRA = calculated panel reactive antibodies

EPTS = estimated post-transplant survival

KPSAM = Kidney-Pancreas Simulation Allocation Model

NM = nautical miles

OPTN = Organ Procurement and Transplantation Network

SRTR = Scientific Registry of Transplant Recipients

1Stewart DE, Wilk AR, Toll AE, et al. Measuring and monitoring equity in access to deceased donor kidney transplantation. Am J Transplant. 2018;00:1–12. https://doi.org/10.1111/ajt.14922.

Public comment open Aug. 2 through Oct. 2

Aug. 2, 2019 — The Organ Procurement and Transplantation Network (OPTN) is offering eight proposals for public comment, Aug. 2 through Oct. 2.

  • Eliminate the use of DSA and region in kidney allocation policy
  • Eliminate the use of DSA and region in pancreas allocation policy
  • Expedited liver placement
  • Modify data submission policies
  • Clarification of pre-existing liver disease
  • Data collection to evaluate the logistical impact of broader distribution
  • Modify appointment process for histocompatibility committee vice-chair
  • Continuous distribution of lungs concept paper

View information, comments and replies on https://optn.transplant.hrsa.gov/governance/public-comment/, to promote transparency and trust in the national transplant system. Visitors can also share comments on social media, if they wish.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals and provide valuable feedback to help shape U.S. organ transplant policy. At-a-glance summaries explain the proposed changes and why they may matter to you. 

Informational webinars

The purpose of these webinars is to give everyone an opportunity to learn about the proposals. 

Register for upcoming webinars and view recordings

After public comment closes, we review all comments we receive about a proposed change before the OPTN Board of Directors votes on it.

Kidney and pancreas committees refine distribution policy options

July 4, 2019 — The OPTN kidney transplantation and pancreas transplantation committees met June 25 in Baltimore to continue developing proposals to increase equity in access by replacing donation service area (DSA) and regional boundaries in kidney and pancreas distribution.

“Both our committees reviewed the recent SRTR modeling of policy options,” said Silke Niederhaus, M.D., vice chair of the pancreas transplantation committee.  “We saw that many of the options had very similar impacts on key outcomes, so we were able to narrow the options we will pursue further.”

Both committees resolved not to continue active study of the options utilizing circles of 150 nautical miles from the donor locations, since their modeled outcomes did not reveal significant enough benefits to restrict distribution to that radius. 

Each committee and a joint workgroup will continue to refine and discuss options based on circles of either a 250 or 500 nautical mile radius.  They will review refined analysis comparing the alternative approaches to one another and to the baseline simulation of current allocation policy.

“We will continue to discuss options that best address needed improvements to equity and patient access,” said Nicole Turgeon, M.D., chair of the kidney transplantation committee.  “We have an opportunity not simply to replace our use of DSAs and regions but to make things better for all our patients.”

The committees and workgroup will also carefully weigh community and public input, including comments and questions from webinars held June 27 and 28.

For additional information or to share other perspectives, contact Ross Walton at ross.walton@unos.org or (804) 782-4942, or Tina Rhoades at tina.rhoades@unos.org or (804) 782-1551.

National kidney and pancreas webinars discuss SRTR modeling results

June 24, 2019 — The OPTN kidney transplantation and pancreas transplantation committees are developing organ distribution proposals to replace current Donation Service Area (DSA) and regional boundaries used in the current system. SRTR modeling of alternatives to inform these policy proposals is available.

The committees sponsored national webinars in June to further discuss SRTR modeling, outline the plans for further policy development, and seek public feedback prior to the committees submitting proposals for public comment.  View webinar recordings to learn more.

The committees will discuss the modeling results and webinar input and publish proposals for public comment period beginning August 2.

Public comment open Jan. 2 through March 22, 2019

Jan. 22, 2019 — The Organ Procurement and Transplantation Network (OPTN) is offering nine proposals for public comment beginning on Tuesday, January 22.

Comments and replies will be published on https://optn.transplant.hrsa.gov/governance/public-comment/, to promote transparency and trust in the national transplant system. Visitors can also share comments on social media, if they wish.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals and provide valuable feedback to help shape U.S. organ transplant policy.

These are the proposals available for public comment:

  • Clarifications on Reporting Maintenance Dialysis
  • Eliminate the Use of DSA and Region from Kidney and Pancreas Allocation
  • Eliminate the Use of DSAs in Thoracic Distribution
  • Eliminate the Use of Regions in VCA Distribution
  • Ethical Implications of Multi-Organ Transplants
  • Expedited Placement of Livers
  • Guidance on Effective Practices in Broader Distribution
  • Modify HOPE Act Variance to Include Other Organs
  • Split Liver Variance

Discussion webinars

The purpose of these webinars is to give everyone an opportunity to learn about the proposals on the discussion agenda.

See webinar dates and register.

Public comment closes on March 22. We review all comments we receive about a proposed change before the OPTN Board of Directors votes on it.

SRTR modeling results available for kidney and pancreas distribution proposal

Dec. 10, 2018 — The OPTN kidney transplantation and pancreas transplantation committees are developing proposed kidney and pancreas distribution policies to replace current Donation Service Area (DSA) and regional boundaries used in the current system. SRTR modeling of alternatives to inform the proposal is available via the following links: 

The committees will discuss the modeling results and develop a proposal for public comment beginning January 22 and ending March 22, 2019. Look for additional updates on the geographic organ distribution page of the OPTN website.

Who makes policy?

Learn how we develop policy together

The role of public comment

OPTN Committees

OPTN regions and regional meetings

Join the process: how to get involved


What are the kidney and pancreas proposals under consideration?

Proposal to eliminate the use of DSA and Region in kidney allocation

Proposal to eliminate the use of DSA and Region in pancreas allocation

SRTR modeling results: kidney and pancreas distribution analysis

Allocation proposal maps: view donor hospitals within 250 NM of kidney transplant centers

What happened in public comment?


More kidney and pancreas resources:

OPTN Kidney Transplantation Committee webpage and meeting minutes

OPTN Pancreas Transplantation Committee webpage and meeting minutes

KAS: the Kidney Allocation System

View a webinar with information for transplant patients and families

Additional kidney and pancreas information


Previous committee steps

Read the January 2019 joint concept paper “Eliminate the Use of DSAs and Regions in Kidney and Pancreas distribution”

Read the June 2019 Kidney/Pancreas Workgroup OPTN Board Report

Quotation marks to indicate quoted text

“The appropriateness of the concentric circle model for kidney allocation is mostly supported, but there are differences in opinion. What is not being discussed are the differences in criteria of acceptances of organs between centers and how that affects a center’s time to organ offer for their candidates. Along with changes in allocation will likely come changes in practice of organ acceptance, and this will need to be tracked, so centers can learn more about how organs they did not accept fared.”

Michael Schilsky, M.D., Director of Hepatology, Yale NHH

Region 1 meeting comment on the proposal to eliminate DSA and Region from kidney allocation policy

Quotation marks to indicate quoted text

“…I support the proposal as an interim path toward Continuous Distribution, though please note that I prefer 250nm circles. While I understand the concerns of many of the commenters with respect to other changes that could be made instead, the fact of the matter is that, while there are many changes that can be done (increasing OPO performance, discussing opt-in vs. opt-out, etc.), those other changes should be considered separately. That is, this proposal is not mutually exclusive to other such changes, and this change is important to both fulfill the requirements of NOTA/Final Rule, and to ensuring that we are taking every individual step we can to improve the system…”

Joseph Hillenburg

OPTN public comment on the proposal to eliminate the use of DSA and Region in pancreas allocation policy

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