Islet Cell Transplantation in the Context of a Clinical Trial

Medicare covers pancreatic islet cell transplantation and associated routine costs (including acquisition, delivery, inpatient/outpatient care, immunosuppressants, and follow-up) for Medicare beneficiaries only when performed as part of NIH-sponsored clinical trials. Partial pancreatic tissue transplantation and any islet cell transplantation performed outside a clinical trial remain noncovered; documentation must demonstrate trial enrollment, Type 1 diabetes diagnosis, and compliance with routine-care definitions in NCD 310.1.

"Medicare covers routine costs, transplantation, and related items/services for Medicare beneficiaries participating in NIH-sponsored clinical trials of pancreatic islet cell transplantation."

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