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Current Regulations Regarding Pancreatic Islet Transplantation in the US. 

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• Although pancreatic islet allotransplantation for patients with T1DM has been performed in the USA for last 16 years, it is still considered a research, an experimental procedure.

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• Regulations introduced by FDA and CMS for islet transplantation over 16 years led to the first clinical trial for islet  Tx sponsored by NIH (Collaborative islet Transplantation- CIT).

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• According to regulations at that time, Tx centers were required to pay a full clinical organ acquisition fee but CMS or NIH  were reimbursing that cost to Tx centers.

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• Once the trial was accomplished over 7 years, CMS and NIH stopped reimbursing centers for the organ acquisition fee, but CMS instructions for OPOs has NOT been adjusted. 

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• Therefore, OPOs often feel still obligated charging the same high, clinical organ acquisition fee but the difference is that neither CMS, nor NIH and  any the insurance company reimburse tx centers for that.

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• Unfortunately, islet Tx procedure still remains experimental  in the US and performed ONLY as a clinical RESEARCH studies completely funded by Tx Centers., with No CMS, NIH or any insurance company support. 

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•  In such situation Tx centers cannot afford paying such a high clinical organ aqusition fee so they stop accepting pancreata and stop performing islet Tx research and procedures.. As a result, now the whole field of islet transplantation is about to extinct in the US, whereas it is in progress in Canada, Europe and Australia. 

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• Current regulations regarding pancreas for islet transplantation today in the US cause that every day human pancreata offered as a gift of life by a generous donor and donor's family are wasted, not recovered instead of benefiting other people, very sick patients, benefitting research and progress in the field..

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• All together, CMS should NOT require from OPO anymore to charge a full clinical organ acquisition fee ($25,000- $50,000) from research Transplant Centers for performing still experimental procedure, since CMS stop reimbursing centers for that.  

• Accordingly, OPO should charge the same research fee for pancreas used for research islet transplantation, the same fee as applied to any other organ for research purposes.

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Why do we look for partnerships with Organ Procurement Organizations? 

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Having exciting outcomes with islet transplants alone (see our patient stories), we would like also to prove safety and effectiveness of islet transplantation in a different group of T1DM patients, those who have already received kidney transplant and are established on stable immunosuppression. We believe, that islet transplantation would substantially improve patient's glucose control and quality of life by preventing progression of secondary diabetic related complications without major surgery related to a whole pancreas transplantation.. 

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As we know, organ acquisition fees paid by transplant centers allows OPOs to recover the cost of their activity.

Transplant centers then recover their cost from insurance after completion of the clinical transplant.

However, such mechanism of financing does not exist for islet transplantation any more, as described above..

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What are we asking for?

 

Since islet transplantation can only be performed as a research/experimental procedure, 

we feel that it is our obligation to ask our partners  and leaders of OPOs to apply research rates, when a pancreas is utilized for islet transplantation instead of the full clinical rate for donor pancreas acquisition fee that is applied for whole pancreas transplant. 

 

At the same time, we would like to highlight that:

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• Pancreas allocation for whole organ transplantation still remains the priority for donor pancreas placement. Only when donor pancreas is declined by all whole pancreas transplant centers, it could be then allocated to the islet center for transplant in the setting of a clinical study approved by the FDA and IRB. 

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• Additionally, optimal pancreas donor characteristic for islet transplantation is very different than for whole organ transplantation and allocation for islet would not compete with allocation for pancreas transplant but be supplementary  (see donor criteria below). 

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• The number of islet transplant procedure will be very low- only few per year for a single OPO, so it would NOT affect overall particular OPO cost and budget. 

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Rationale:

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1. Research rate for organ recovery has been introduced to promote research, improvement  and progress in the field of transplantation and to honor our donors wish to contribute to the research and development of new therapies. 

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2. Currently, human pancreata rejected for whole organ transplant are frequently wasted, taken to the grave, simply because extremely high clinical organ acquisition fees are required by OPOs and are cost prohibitive to research centers.

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3. A common misconception is that organ acquisition fees for islet transplantation are recovered by the transplant center through insurance reimbursment, when in fact, the cost is NOT recovered in any way. Organ  acquisition fee comes directly out of the center's research funding, precluding completely or  limiting the number of islet transplants that can take place. 

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4. Fortunately, there have been a few OPOs understanding the current situation and have tried to help our patients charging only a research fee. We and our patients are grateful for thist. We hope that more OPOs would be able to help in such way, contribute to the progress of the field as well to benefit everyone. 

 

Benefits for everyone:

 

Partnership of  OPOs and islet Tx centers with application of a research rates for the pancreas recovery for islet transplant would benefit everyone involved:

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1. Patients would benefit from novel procedures and approaches in the controlled environment of clinical trials approved by the FDA and IRB.

2. Transplant field would benefit by promotion of  progress  and innovation.. 

3. OPOs- as more organs would be utilized to the fullest potential, more funds are recovered from procurements leading  to more robust activity. 

 

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Criteria for pancreas donor for islet transplantation 

 

Exclusion criteria:

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1. High CDC risk 

2. HCV, HIV or HBV positive 

3. Diabetes or A1c>6

4. BMI <20

5. Age <18 and >65

6. Sepsis

7. Pancreas pathology, trauma or transection during liver recovery

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Preferred criteria (donors, who are especially desired):

1. Obese, (BMI>28)

2. Tall male

2. Heavy drinkers

3. Age >22 but below 60

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