Blue Cross Blue Shield of Minnesota Medical Policy


Medical Policy:
Islet Transplantation
Effective Date:
April 27, 2020
Issued Date:
May 3, 2021
Last Revision Date:
April 2020
Annual Review:
April 2021

This policy version was replaced May 30, 2022. To find the newest version, go to, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Autologous islet transplantation is a technique developed to prevent or delay the onset of insulin-dependent diabetes in patients who have undergone total or near-total pancreatectomy for the treatment of chronic pancreatitis. In this procedure, islet cells from the patient’s pancreas are transplanted to the patient’s liver. The pancreas is first removed and is sent to a special laboratory for islet preparation. Islet cells are then collected, placed in syringes, and transplanted into the patient via the portal vein system. Islets are injected slowly into the portal vein, and portal vein pressure is measured during the infusion. Once in the portal vein, the blood flow and pressure carry the islets to the liver where they encounter small diameter capillaries that can’t be traversed by the islets. The islets become engrafted in the liver.

Allogeneic islet cell transplantation is being investigated as a treatment for a subset of patients with type 1 diabetes who have a history of severe metabolic instability. During allogeneic islet transplantation, islet cells are first isolated from the pancreas of one or more cadaver donors and then transplanted into the patient via the portal vein system. Because allogeneic islet cells meet the definition of a drug under the federal Food, Drug, and Cosmetic Act, clinical trials are required to determine safety and effectiveness according to investigational new drug regulations. Currently, allogeneic pancreatic islet cell products are not approved by the U.S. Food and Drug Administration (FDA) outside the setting of a clinical trial.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I.  Autologous islet transplantation may be considered MEDICALLY NECESSARY AND APPROPRIATE as an adjunct to a total or near total pancreatectomy in patients with chronic pancreatitis.

II.  Allogeneic islet transplantation is considered EXPERIMENTAL/INVESTIGATIVE for the treatment of type I diabetes due to lack of evidence demonstrating an impact on improved health outcomes.

III.  Autologous and allogeneic islet transplantation is considered EXPERIMENTAL/INVESTIGATIVE for all other indications.

0584T 0585T 0586T 48160 G0341 G0342 G0343 S2102

Documentation Submission:

Link to Transplant Pre-Authorization Form:

Denial Statements

No additional statements.


Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.


CPT® codes copyright American Medical Association® 2022. All rights reserved.

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