SPK may be considered medically necessary for individuals who have insulin-dependent diabetes mellitus with uremia or end-stage renal disease.
Candidates for all types of pancreas/kidney transplant may be considered medically necessary when ALL of the following are met:
- Adequate cardiopulmonary status; and
- Absence of active infection; and
- No history of malignancy within five (5) years of transplantation, excluding non-melanomatous skin cancers; and
- Documentation of individual compliance with medical management.
Absolute contraindications for transplant recipients include, but are not limited to, the following:
- Metastatic cancer; or
- Ongoing or recurring infections that are not effectively treated; or
- Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery; or
- Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured; or
- Demonstrated individual noncompliance, which places the organ at risk, by not adhering to medical recommendations; or
- Potential complications from immunosuppressive medications are unacceptable to the individual; or
- Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control (CDC) definition of CD4 count, 200 cells/mm3) unless the following are noted:
- CD4 count greater than 200 cells/mm3 for greater thansix (6) months; and
- Human immunodeficiency virus (HIV) -1 ribonucleic acid (RNA) undetectable; and
- On stable anti-retroviral therapy greater than three(3) months; and
- No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioide-mycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm); and
- Meeting all other criteria for pancreas/kidney transplantation.
Relative contraindications to pancreas/kidney transplantation include, but are not limited to, the following:
- Inability to adhere to the regimen necessary to preserve the transplant; or
- Malignant neoplasm (other than non-melanomatous skin cancer) that has a significant risk of recurrence; or
- Severe uncorrectable cardiac disease (e.g., coronary angiographic evidence of significant non-correctable coronary artery disease, refractory congestive heart failure, ejection fraction below 40%, myocardial infarction less than three (3) months ago). Cardiac status should be reevaluated annually while on waiting list; or
- Unresolvable current psychosocial problems; or
- Chronic liver disease; or
- Clinical evidence of severe cerebrovascular or peripheral vascular disease (e.g., ischemic ulcers, previous amputation secondary to vascular disease). Adequate peripheral arterial supply should be determined by standard evaluation in the vascular laboratory including Doppler examination and plethysmographic readings of systolic blood pressure; or
- Past psychosocial abnormality; or
- Persons with body mass index (BMI) of 35 or higher and type 2 diabetes (bariatric surgery should be considered); or
- Structural genitourinary abnormality or recurrent urinary tract infection; or
- Substance abuse history (other than persistent substance abuse); or
- Treated malignancy (simultaneous pancreas/kidney transplantation is considered medically necessary in persons with malignant neoplasm if the neoplasm has been adequately treated and the risk of recurrence is small); or
- Uncontrolled hypertension.
SPK transplantation performed for any other indications than those listed in this policy or for those individuals presenting with an absolute contraindication are considered not medically necessary.
One pancreas alone, one pancreas after kidney or one simultaneous pancreas/kidney (SPK or SPLK) re-transplantation after failure of the primary graft may be considered medically necessary when the individual meets ALL the transplant criteria above.
One pancreas alone, one pancreas after kidney or one simultaneous pancreas/kidney (SPK or SPLK) re-transplantation for all other indications is considered not medically necessary.