CMS Pub. 100-03, ch. 1, § 260.3

A. General

Pancreas transplantation is performed to induce an insulin-independent, euglycemic state in

diabetic patients. The procedure is generally limited to those patients with severe secondary

complications of diabetes, including kidney failure. However, pancreas transplantation is

sometimes performed on patients with labile diabetes and hypoglycemic unawareness.

B. Nationally Covered Indications

Effective for services performed on or after July 1, 1999, whole organ pancreas transplantation is

nationally covered by Medicare when performed simultaneous with or after a kidney transplant.

If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy begins

with the date of discharge from the inpatient stay for the pancreas transplant.

Effective for services performed on or after April 26, 2006, pancreas transplants alone (PA) are

reasonable and necessary for Medicare beneficiaries in the following limited circumstances:

1. PA will be limited to those facilities that are Medicare-approved for kidney

transplantation. (Approved centers can be found at

http://www.cms.hhs.gov/ESRDGeneralInformation/02_Data.asp#TopOfPage.)

2. Patients must have a diagnosis of type I diabetes:

• Patient with diabetes must be beta cell autoantibody positive; or

o Patient must demonstrate insulinopenia defined as a fasting C-peptide level that is

less than or equal to 110% of the lower limit of normal of the laboratory's measurement

method. Fasting C-peptide levels will only be considered valid with a concurrently obtained

fasting glucose <225 mg/dL.

3. Patients must have a history of medically-uncontrollable labile (brittle) insulin-dependent diabetes mellitus with documented recurrent, severe, acutely life-threatening

metabolic complications that require hospitalization. Aforementioned complications include

frequent hypoglycemia unawareness or recurring severe ketoacidosis, or recurring severe

hypoglycemic attacks;

4. Patients must have been optimally and intensively managed by an endocrinologist for at

least 12 months with the most medically-recognized advanced insulin formulations and

delivery systems;

5. Patients must have the emotional and mental capacity to understand the significant risks

associated with surgery and to effectively manage the lifelong need for immunosuppression;

and,

6. Patients must otherwise be a suitable candidate for transplantation.

C. Nationally Non-Covered Indications

The following procedure is not considered reasonable and necessary within the meaning of

section 1862(a)(1)(A) of the Social Security Act:

1. Transplantation of partial pancreatic tissue or islet cells (except in the context of a

clinical trial (see section 260.3.1 of the National Coverage Determinations Manual).

D. Other

Not applicable.

(This NCD last reviewed April 2006.)