1. Removal of DSA and Region from Kidney and Pancreas Distribution
Kidney and Pancreas Transplantation Committees
Introduce yourself, your committee and what organization you’re from.
Note that this is a joint project between the kidney and pancreas committees, and we are looking for feedback on both distribution systems so please keep that in mind when you listen to the proposal. A pancreas committee member will join later in the presentation and be available to answer questions as well.

2. Important Considerations
Proposed solutions represent a list of policy options the KP workgroup chose to model
KP Workgroup continues to consider framework variations not included in this concept paper
No decisions made about potential policy solutions
Concept paper is being pursued to solicit community feedback on Workgroup progress and findings as well as variation preferences
Kidney committee continues to deliberate further prioritization of pediatrics and prior living donor candidates in classification tables
These are important considerations to keep in mind during this proposal.
The proposed solutions we will discuss represent options the kidney pancreas (KP) workgroup chose to model. However, the KP Workgroup may also consider other policy solutions based on community feedback and additional evidence gathered. No decisions have made about potential policy solutions.
We’re looking to get feedback on the different options presented in this presentation and in the concept paper.
It is important to note that the Kidney Committee continues to deliberate further prioritization of pediatrics and prior living donor candidates in classification tables. This may be part of the ultimate policy solution submitted to the community for public comment.

3. What problem does the paper address?
Ensure compliance with the Final Rule by proposing potential solutions to remove DSA and region from allocation policies
Concept paper does not change policy
Purpose to inform and gather feedback on options for:
Removing DSA and region in kidney and pancreas distribution
Aligning allocation policies with the Final Rule
Moving kidney and pancreas policy towards single allocation framework
This proposal seeks to ensure compliance with the Final Rule by proposing potential solutions to remove DSA and region from allocation policies.
The concept paper does not propose a change to policy. It serves to gather feedback and more evidence on policy solutions before such a solution is issued for public comment.
The purpose is to inform and gather feedback on options for:
Removing DSA and region in kidney and pancreas distribution
Aligning allocation policies with the Final Rule
Moving kidney and pancreas policy towards a single allocation framework

4. What are the possible solutions?
Fixed concentric circle framework with a 150 nautical mile (NM) small circle and a 300 NM large circle
Fixed concentric circle framework with a 250 NM small circle and a 500 NM large circle
Fixed concentric circle framework with a single 500 NM circle
Hybrid framework with a single 500 NM circle that uses a small number of proximity points inside and outside of the circle
Hybrid framework with a single 500 NM circle that uses a large number of proximity points inside and outside of the circle
These are the potential solutions that the Committees requested modeling for.
For each potential solution, the classification tables within kidney and pancreas policies would still determine the order in which potential transplant recipients would appear on the match run.
The next slides will go into more detail about the potential solutions.

5. 150 NM/300 NM Fixed Concentric Circles
One potential solution considered by the committees replaces DSA and region with two fixed distance circles from the donor hospital. This solution would replace DSA with 150 nautical miles and region with 300 nautical miles.
The map on this slide shows 150 and 300 nautical mile circles around top volume donor hospitals to illustrate how distribution would change if “DSA” and “region” were replaced with these fixed distance circles. Darker circles represent 150 miles and lighter circles represent 300 miles, with white dots representing donor hospitals and black dots representing kidney transplant centers.

6. 250 NM Fixed Concentric Circles
Another fixed concentric circle solution would be replacing DSA with 250 nautical miles and region with 500 nautical miles.
This figure shows all kidney transplant hospitals with 250 NM circles around the top volume donor hospitals in order to illustrate how distribution would change if a 250/500 fixed concentric circle model were adopted. (500 nm circles are illustrated on the next slide)

7. 500 NM Fixed Concentric Circles
This figure shows 500 NM circles around top volume donor in order to illustrate how distribution would appear for the 250/500 fixed concentric circle model.

8. 500 NM Circle, No Proximity Points
Another solution considered by the committees would replace DSA with a single 500 nautical mile circle and eliminate regional classifications. This represents a fixed concentric circle framework with one circle.
Organ offers would go to candidates within the 500 NM circle before the offers would go to candidates outside the 500 NM circle (except for those exceptions noted in policy, such as mandatory national shares for the most highly-sensitized candidates).

9. 500 NM Circle, Shallow Proximity Points
The committees also considered hybrid solutions that incorporated elements of the fixed circle framework and continuous distribution.
This figure shows how a single 500 NM circle with shallow proximity points would work. As with the previous variation, DSA would be replaced with 500 nm from the donor hospital, and regional classifications would be eliminated. However, a small number of proximity points would be awarded to candidates closer to the donor hospital. Candidates would receive up to one point inside the circle, and up to two points when allocation moves outside of the circle.
A candidate registered at a transplant hospital 500 NM away from the donor hospital would receive no proximity points. Proximity points are awarded linearly between those two points, so a candidate registered at a hospital 250 NM from the donor hospital would be awarded 0.5 points.
If no candidates within the 500 NM circle accept the organ offer, the organ moves out to national distribution. A candidate registered just outside the 500 NM circle would be awarded two proximity points and a candidate registered 2500 NM and beyond from the donor hospital would be awarded no proximity points.

10. 500 NM Circle, Steep Proximity Points
This solution is also a “hybrid” approach that incorporates elements of concentric circles and continuous distribution. It is identical to the previous solution, except the steepness of the proximity points is doubled both inside and outside the circle. Candidates would receive up to 2 points inside the circle, and up to 4 points when allocation moves outside of the circle.
Distance (NM) from Donor Hospital to Waiting List Candidate (Listing Center)

11. SRTR modeling of variations
Updated cohort of kidney, kidney-pancreas, pancreas candidates from Jan – Dec
No impact on waitlist mortality across organs
Lower kidney, pancreas transplant rates compared to baseline
Increased kidney-pancreas transplant rates compared to baseline
The SRTR performed modeling based on an updated cohort of kidney, kidney-pancreas, pancreas candidates from 2017.
Some of the key findings include:
No impact on waitlist mortality across organs
Lower kidney, pancreas transplant rates compared to the baseline for all variations
Increased kidney-pancreas transplant rates compared to baseline

12. Limitations of KPSAM
Overall, modeling projected decline in transplant rates and counts for kidney and pancreas alone, however:
Modeling does not account for changes in behavior
Acceptance behavior likely to change in response to organ availability at a center
Previous experience with the SAMs suggests that they under-predict the number of transplants that would occur in reality if a given policy scenario were adopted
Transplant counts and rates unlikely to decline in reality
It is important to note some limitations of the KPSAM modeling
Overall transplant rates declined across kidney and pancreas alone modeling, however:
Modeling does not account for changes in behavior
Acceptance behavior likely to change in response to organ availability at a center
Previous experience with the SAMs suggests that they under-predict the number of transplants that would occur in reality if a given policy scenario were adopted
SRTR consistently stated to the KP workgroup that the KPSAM modeling is limited to current application practices. According to the SRTR, “the KPSAM was fit on acceptance occurring within a local (DSA), regional, and national framework, wherein there’s a strong preference for local offers. Acceptance behavior will likely change in response to changes in organ availability at a center, and transplant counts and rates may not decline in reality.”

13. Impact on Subgroups in SRTR modeling
Pediatric kidney transplant rates increased compared to adults
High-cPRA kidney, kidney-pancreas and pancreas transplant rates increased
Relatively more kidney and pancreas transplants occurred in African-American recipients compared to white recipients
Relatively more kidney transplant counts for:
Recipients with > 10 years of dialysis time
Recipients with 0-DR mismatches
This slide shows the impact on vulnerable populations and subgroups shown in the SRTR KPSAM modeling. Overall, positive impact was seen on several subgroups that can be considered vulnerable:
Pediatric kidney transplant rates increased compared to adults
High-cPRA kidney, kidney-pancreas and pancreas transplant rates increased
Relatively more kidney and pancreas transplants occurred in African-American recipients compared to white recipients
Relatively more kidney transplant counts for:
Recipients with > 10 years of dialysis time compared to recipients with less time
Recipients with 0-DR mismatches

14. Projected changes in travel distance
One of the key takeaways from the SRTR modeling requested by the Workgroup are the projected changes in the shape of distribution by distance. At their October 15th, 2018 meeting, the majority of the Kidney Committee agreed that broader distribution of kidneys is a value that they would like to see strengthened in whichever framework variation is selected.  
In this figure, the top-left square represents kidney allocation, the top-right square represents kidney-pancreas allocation, and the bottom-left square represents pancreas allocation. From left to right, the distribution shapes represent the baseline (orange), single circle models (yellow), and the fixed concentric circles models (blue).
Each of the five proposed models would broaden kidney and kidney-pancreas distribution compared to the baseline, which represents distribution under the current policy. By contrast, pancreas alone distribution is projected to be less broad compared to the baseline. As noted before, pancreas alone represents a minority of all pancreas transplants, with a majority being comprised of KP transplants.
Orange = Baseline (Current policy)
Yellow = Hybrid framework variations
Blue = Fixed Concentric Circle Variations

15. Main metrics - Kidney
Modeling conducted by the SRTR based on a data request submitted by the Workgroup produced the results in this figure. This figure shows no change in waitlist mortality across the modeling options. As previously discussed, the projected decline in transplant rate/count is due to limitations of SRTR modeling, so caution should be taken in drawing policy conclusions from those particular metrics.
From top to bottom, the distribution scenario labels represent the baseline, 1 circle options, and 2 circle options.
Each model was run with 10 iterations to provide a measure of variability. The average results, along with the minimum and maximum, are provided.
Although the models show a reduction in transplants, this is likely because modeling is based on current acceptance behaviors that reflect allocation based on DSAs and OPTN Regions.

16. Main metrics – Kidney-pancreas
Modeling conducted by the SRTR based on a data request submitted by the Workgroup produced the results in this figure. For kidney-pancreas, an increase in transplant rates and counts was projected, but similar to kidney, waitlist mortality rate held steady across modeling options.
To discuss the specific feedback requested by the committees, my pancreas committee colleague will join me to review these questions.
Although the models show a reduction in transplants, this is likely because modeling is based on current acceptance behaviors that reflect allocation based on DSAs and OPTN Regions.

17. Specific Feedback Requested
What is your opinion of the 150/300 NM circles option?
What is your opinion of the 250/500 NM circles option?
What is your opinion of the 500 NM circle/no points option?
What is your opinion of the 500 NM circle/shallow points option?
What is your opinion of the 500 NM circle/steep points option?
Should there be different distribution systems for kidney and pancreas organs?
PANCREAS COMMITTEE MEMBER:
Hi everyone, I’m [name], a regional representative of the pancreas committee. As [name of kidney representative, or ‘my colleague’] emphasized, this is a joint concept paper put forward by both the kidney and pancreas committees. We would like to gather feedback from the community that can inform a policy solution to modify kidney and pancreas distribution. This policy solution will be presented in fall 2019 public comment.
Specifically, we would like feedback on each of the options presented, and whether there should be different distribution systems for kidney and pancreas. We want to hear both pancreas and kidney perspectives on the relative merits of the potential solutions discussed in the concept paper and in this presentation.
Feedback should be grounded in evidence tied to the Final Rule, such as the impact on efficiency in organ placement or on achieving the best use of donated organs.
After the presentation, you’ll be asked to key in your answers, indicating whether you strongly support, support, are neutral or abstain, oppose, or strongly oppose each of these six questions.
Note: these questions refer jointly to changes in kidney and pancreas allocation.

18. Specific Feedback Requested
How do you think replacing DSA and Region with either fixed concentric circles or the hybrid framework outlined in this presentation would affect organ acceptance behavior
Example: recovery practices of an OPO; evaluation of offers for a transplant program
Modeling is limited in predicting changes in transplant center and OPO behavior as a result of allocation policy changes
We also would like feedback on how your organization’s acceptance practices may change if DSA and region were removed from policy and replaced with one of the two frameworks outlined in this presentation – fixed distance circles, and the hybrid approach.
Because modeling is limited in predicting changes in transplant center and OPO behavior, feedback would be helpful in indicating how your organization’s behavior would change if the policies were modified.
For these questions, we encourage feedback and discussion, and are not polling the room, because the feedback we’re looking for is more qualitative in nature.
[prompting questions if no one speaks up:
For example, if you’re from an OPO, how do you think replacing DSA and region would impact recovery practices?
For a transplant program, how do you think the evaluation of offers would change? ]

19. Questions?

20. Extra Slides

21. Collaboration between kidney and pancreas committees
Committees worked together to develop SRTR modeling for both allocation systems
Why for both?
Most pancreata transplanted as kidney-pancreas (KPs)
Could be logistically challenging to have different systems
Not clear why the distribution for pancreas and kidney would need to be different
However…
Through Committee and Workgroup deliberation, members recognized the distribution systems may need to have separate solutions

22. Collaboration between kidney and pancreas committees
Concerns raised about same distribution distances for kidney and pancreas:
Pancreata have different acceptable ischemic time from kidneys
Distribution of pancreas programs fewer in number and more spread out
Procurement methods may be different
Issues of organ scarcity and discard rate may apply differently for kidney and pancreas
Different challenges to applying hybrid solution to pancreas allocation than KAS, that has points
Conclusion- gather more feedback from community and gather more evidence to make informed decision based on Final Rule:
Demonstrate sound medical judgment with data driven evidence
Achieve best use of donated organs
Promote the efficient management of organ placement measured in travel time and costs