This document addresses pancreas alone or a pancreas/kidney transplant which involves the removal of human organs from a deceased or living donor with the implantation into a single recipient.

Position Statement

Note: Members must meet the disease specific criteria as well as the General Individual Selection criteria below for the transplantation to be considered medically necessary.

Medically Necessary:

Simultaneous deceased-donor pancreas/kidney transplant (SPK) is considered medically necessary for individuals with insulin dependent diabetes mellitus (IDDM) who have end-stage renal disease.

Simultaneous deceased-donor pancreas and living-donor kidney transplant (SPLK) is considered medically necessary for individuals with insulin dependent diabetes mellitus who have end-stage renal disease. 

Pancreas transplant alone (PTA) either deceased or living-donor segmental is considered medically necessary for individuals who have insulin dependent diabetes mellitus with severe disabling and documented life threatening hypoglycemic unawareness due to labile diabetes which persists despite optimal medical management.

Pancreas after kidney transplant (PAK) is considered medically necessary for individuals with insulin dependent diabetes mellitus.

One pancreas alone, one pancreas after kidney or one simultaneous pancreas/kidney (SPK or SPLK) re-transplantation after failure of the primary graft is considered medically necessary provided the individual meets the transplant criteria above.

Investigational and Not Medically Necessary:

Pancreas transplantation is considered investigational and not medically necessary for all other applications.

A third or subsequent pancreas alone, pancreas after kidney or SPK or SPLK transplantation is considered investigational and not medically necessary in all cases.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

General Individual Selection Criteria

In addition to having the clinical indications above, the member must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications- for Transplant Recipients include, but are not limited to, the following:

1. Metastatic cancer
2. Ongoing or recurring infections that are not effectively treated
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured
5. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations
6. Potential complications from immunosuppressive medications are unacceptable to the patient
7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and
   Prevention [CDC] definition of CD4 count, 200 cells/mm³) unless the following are noted:
   1. CD4 count greater than 200 cells/mm³ for greater than 6 months
   2. HIV-1 RNA undetectable
   3. On stable anti-retroviral therapy greater than 3 months
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm)
   5. Meeting all other criteria for pancreas or pancreas/kidney transplantation.

Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.