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Why was the pancreas/kidney‐pancreas allocation system changed in 2014?
Before October 2014, there was no nationally established allocation practice for patients with diabetes and renal failure. Previous pancreas allocation policy allowed OPOs several choices on pancreas allocation practice. They could allocate organs to kidney pancreas (KP) candidates based upon the KP match run, the kidney‐alone (KI) match run, or a combination of match runs.
In the past, transplant centers could list candidates on separate or combined kidney‐pancreas (KP)/pancreas‐alone (PA) waiting lists. Consequently, waiting time for KP transplant varied widely across the country because of local or regional allocation decisions. Also, the previous practice did not maximize the utilization of the pancreas.
What were the goals of the new national Pancreas/Kidney‐Pancreas Allocation System?
The main goals are to:
- Improve the opportunity for pancreas candidates to receive a transplant. Currently, diabetic, uremic candidates are not motivated to receive a kidney from a living donor and then wait on the list for only a pancreas because most donation service areas allocate organs to KP candidates before allocating them to PA candidates. This situation discourages candidates who need both a kidney and a pancreas to take a living donor kidney followed by a deceased donor pancreas.
- Establish a uniform, national system to govern how pancreas allografts are allocated.
- Increase utilization and reduce geographic inequities related to deceased donor pancreas allocation, access to transplantation, and the duration of a candidate’s waiting time.
- Standardize the pancreas allocation process to increase access to organs and reduce waiting times for both KP and PA candidates without significantly adversely affecting access and waiting times for KI candidates, including impact on ethnicity, age, and gender.
- Develop appropriate qualifying criteria for candidates waiting for a KP transplant.
- Enhance operational efficiency, reduce computer programming requirements, and decrease OPO and OPTN administrative costs for pancreas allocation by disentangling KPs from the kidney allocation system.
What are the major changes in the new allocation system?
A major change in the new allocation system is that it creates qualifying criteria for KP candidates. Also KP candidates and PA candidates will be on a single match run.
When did the new rules for Pancreas/Kidney‐Pancreas Allocation System take effect?
The new PA/KP Allocation System was implemented on October 30, 2014.
Will the OPTN Pancreas Transplantation Committee assess data after implementation of the new allocation system?
The committee reviewed KP and PA transplant data 6 months after implementation and every subsequent 6 months for 3 years after implementation. The committee will monitor the impact on pediatric kidney transplantation in particular and will recommend policy modifications if they identify a significant negative impact on pediatric kidney transplantation.
What are the kidney‐pancreas qualifying criteria to accrue waiting time?
In order to accrue KP waiting time, a KP candidate who is 18 years or older, must:
- Be registered for a kidney‐pancreas transplant
- Qualify for kidney waiting time
- Meet one of the following criteria:
- Is on insulin and has a C‐peptide value less than or equal to 2 ng/mL
- Is on insulin and has a C‐peptide value greater than 2 ng/mL and has a body mass index less (BMI) than or equal to the maximum allowable BMI
What if a candidate doesn’t meet the kidney‐pancreas qualifying criteria?
Candidates who do not meet KP qualifying criteria may still be eligible to receive waiting time for a KI or a PA transplant.
What happens if a candidate’s qualifying criteria for the kidney‐pancreas transplant changes?
Once a transplant hospital enters data that qualifies a candidate for a KP transplant, the candidate will remain qualified regardless of subsequent test results.
How are the new kidney‐pancreas qualifying criteria reported?
You must report the following values in UNetSM for all KP candidates:
- C‐peptide date
- On insulin
- Insulin date
- BMI: Height date
- BMI: Weight date
Questions related to qualifying criteria fields
If the patient is only able to approximate the year that they started to use insulin, is that acceptable?
You must be able to corroborate an insulin start date in the candidate’s medical documentation. Site surveyors will review the candidate’s medical record and look for the earliest documented date of insulin use. They will look for a date that precedes the candidate’s registration date. Although documentation is required, it can be in the form of medication administration records, progress notes, doctors’ notes, or even a note in the record that the patient self‐reported their insulin start date.
Does the patient have to have a fasting blood sugar < 200 mg/dl to have a valid c‐peptide result?
The reported c‐peptide value may be fasting or stimulated.
Is there a certain number of years a patient needs to be on insulin?
How often does the weight need to be monitored and reported for KP candidates?
You do not have to monitor or continue to report a KP candidate’s weight after you initially enter it, however, you may choose to update the candidate’s weight. As a reminder, once your KP candidate qualifies to accrue KP wait time, that candidate will remain qualified regardless of subsequent test results.
If a candidate has an undetectable c‐peptide value, how should you report it?
You should report the c‐peptide threshold value. If the c‐peptide value is reported as <X, the threshold (i.e. X) is the acceptable value. For example, if a candidate’s c‐peptide value is reported as <0.1, enter
0.1 for the c‐peptide value.
Existing Kidney/Kidney‐Pancreas Candidates
If a patient was registered for a KP transplant before the changes to the pancreas allocation system are implemented, what happened to their waiting time after the changes are implemented?
KP candidates registered for a KP transplant before October 30, 2014, and who accrued KP waiting time and met kidney waiting time qualifying criteria, had their accrued KP wait time grandfathered at implementation. These KP candidates did not have to meet the new KP qualifying criteria in order to continue to accrue wait time. This means that the candidate did not lose any waiting time they already accrued and would continue to accrue waiting time.
After the changes were implemented, does a KP candidate have to meet the KP qualifying criteria in order to be listed or eligible to receive a KP offer?
Any KP candidate added after the changes to the pancreas allocation system were implemented must meet certain criteria in order to accrue KP waiting time (this includes the medical criteria required to accrue waiting time under the kidney allocation system). However, they are not required to meet the criteria to accrue KP waiting time in order to be listed or to be eligible to receive a KP offer.
If a KP candidate was on inactive status before October 30, 2014, and was changed to active status after October 30, 2014, will that candidate need to meet the new KP waiting time qualifying criteria?
No, that candidate’s active/inactive status is irrelevant, as long as they met qualifying criteria to accrue kidney waiting time and accrued KP wait time before October 30, 2014.
What is the maximum allowable BMI?
If a KP candidate qualifies to begin accruing KP waiting time under the BMI option, then the KP candidate’s BMI must be less than or equal to the maximum allowable BMI. The maximum allowable BMI is 28 kg/m2. (See Policy 11.4.B Kidney‐Pancreas Waiting Time Criteria for Candidates At Least 18 Years Old.)
Can the maximum allowable BMI number change?
Yes, based on public comment feedback, the Pancreas Committee added a measure to allow the BMI threshold in the criteria to accrue KP waiting time to change dynamically.
If the percentage of KP candidates who qualify for KP waiting time because they have a c‐peptide value greater than 2 ng/mL and a BMI less than or equal to the maximum allowable BMI is above 15%, then the BMI threshold will drop by 2 kg/m2.
If the percentage of KP candidates who qualify for KP waiting time because they have a c‐peptide value greater than 2 ng/mL and a BMI less than or equal to the maximum allowable is below 10%, then the BMI threshold will increase by 2 kg/m2. The BMI threshold cannot exceed 30 kg/m2 even if the percentage of candidates on the KP waiting list in this category is below 10%.
The maximum allowable BMI is 28 kg/m2. UNOS checks this percentage every 6 months and sends a report to the Pancreas Committee. The Pancreas Committee will review the report. If a change is indicated, the Pancreas Committee will forward the report to the Executive Committee who will make the official determination that the BMI should be modified in accordance with policy. If no change is indicated, the Pancreas Committee will document its review in its board report.
Can a potential KP candidate be listed with a BMI of 30, when the qualifying BMI is 28?
If a KP candidate qualifies to accrue KP wait time under the BMI option (the candidate is on insulin and has a C‐peptide value greater than 2 ng/mL and has a body mass index less (BMI) than or equal to the maximum allowable BMI) then the KP candidate’s BMI must be less than or equal to the maximum allowable BMI. Beginning on October 30, 2014, the maximum allowable BMI will be 28 kg/m2.
However, if a KP candidate qualifies to accrue KP wait time under the non‐BMI option (the candidate is on insulin and has a C‐peptide value less than or equal to 2 ng/mL) then the KP candidate does not have meet the maximum allowable BMI (i.e. the BMI may be over 28).
Keep in mind, you may list a candidate for a KP, on or after October 30, 2014, without meeting any of the qualifying criteria. However, a listed KP candidate that does not meet the qualifying criteria will not begin accruing waiting time.
How will pancreas‐alone and islet candidates accrue waiting time in the new Pancreas/Kidney‐ Pancreas Allocation System?
Waiting time for PA and islet candidates will begin on the date the candidate is first registered as a PA or islet candidate on the waiting list.
Each PA candidate registered on the PA waiting list must meet one of the following requirements:
- Be diagnosed with diabetes
- Have pancreatic exocrine insufficiency
- Require the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons
How will kidney‐pancreas candidates accrue waiting time in the new Pancreas/Kidney‐Pancreas Allocation System?
For KP candidates at least 18 years old, the KP candidate will begin to accrue KP waiting time when the candidate meets and enters KP qualifying criteria.
How will KP candidates waiting time be calculated in the new Pancreas/Kidney‐Pancreas Allocation System?
KP candidates waiting time is calculated based on the kidney waiting time. On October 30, 2014, a newly registered KP candidate will begin to accrue KP waiting time when that candidate meets and enters the new KP qualifying criteria. As such, this newly registered KP candidate may have already accrued waiting time.
What happens to the waiting time for candidates listed for both a pancreas‐alone and kidney‐ pancreas transplant?
If a candidate is listed for both a KP and PA transplant, the candidate’s waiting times for the KP transplant and PA transplant are independent.
If a patient was listed for a kidney‐only and was later identified as a Kidney‐Pancreas candidate, is the KP candidate eligible to receive the waiting time accrued on the kidney‐only list?
Yes, a KP candidate may receive waiting time they accrued from the kidney only list. (See Policy 11.4.D Waiting Time Assignments for Kidney, Kidney‐Pancreas, and Islet Candidates.)
What do OPOs need to do to prepare for the new Pancreas/Kidney‐Pancreas Allocation System?
OPOs must allocate organs from the combined KP/PA match run before allocating organs from the kidney match run. They need to understand how KP qualifying criteria work and only allow the kidney to follow the pancreas when a candidate is receiving an offer for a KP. The kidney cannot be allocated to a candidate based on his or her PA listing.
What happens when there are other organs available in addition to kidney(s) and pancreas?
If there is only one, local, multi‐organ potential recipient eligible for either a heart, lung, or liver, who also requires a kidney, then the OPO would allocate one kidney according to Policy 5.8 Allocation of Multi‐Organ Combinations. The OPO would allocate the second kidney and pancreas on the combined PA/KP match, according to Policy 11.5.A Kidney‐Pancreas Allocation Order (see Tables 11‐4 and 11‐5). If the potential recipient, who is eligible for a heart, lung, or liver, also needs a kidney but is outside the local area, the OPO must first offer the kidney and pancreas on the combined PA/KP match through the local potential recipients, then offer the kidney(s) to mandatory shares (0mm and paybacks) before allocating a kidney to the non‐local multi‐organ potential recipients.
If the OPO has at least one kidney and a pancreas to offer (and there is no local heart, lung, or liver potential recipient requiring a kidney) then the OPO must offer one kidney and the pancreas on the combined PA/KP match, through the local classification, according to Policy 11.5.A Kidney‐Pancreas Allocation Order (see Tables 11‐4 and 11‐5). Then the OPO must offer the kidney for mandatory shares (0mm and paybacks) on the kidney match run list.
Once the OPO has offered kidneys to: all local multi‐organ potential recipients requiring a heart, lung, or liver and a kidney, the combined PA/KP match run through local potential recipients, and mandatory shares (0MM and paybacks); the OPO may allocate the remaining kidney(s) down the kidney match run, down the combined PA/KP match run to regional/national candidates, or to a non‐local multi‐organ heart, lung, or liver potential recipient requiring a kidney.
Did paybacks go away?
When changes to the Kidney Allocation System were implemented on December 4, 2014, the payback system was eliminated, including paybacks for multi‐organ offers.
What impact will the changes have on pediatric kidney‐pancreas candidates?
If a KP candidate is less than 18 years old at the time of KP registration, then the candidate does not have to meet the KP qualifying criteria.
When will pediatric patients be required to follow adult listing requirements after age 18?
Pediatric KP candidates do not have to meet new qualifying criteria to accrue KP waiting time. After the pediatric KP candidate turns 18, the candidate still does not have to meet the qualifying criteria to accrue KP waiting time.