NCD 260.3

Item/Service Description

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.

Indications and Limitations of Coverage

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:

• PA will be limited to those facilities that are Medicare-approved for kidney transplantation. (Approved centers can be found at http://www.cms.gov/ESRDGeneralInformation/02_Data.asp#TopOfPage

• Patients must have a diagnosis of type I diabetes:

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

• 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;

• 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;

• 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;

• 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,

• 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:

• 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.)

Revision History

05/2006 - Pancreas transplants alone are covered under Medicare in limited circumstances. Effective date 04/26/2006. Implementation date for Carriers no later than 07/03/2006. Effective date for FI's 10/02/2006. (TN 56) (CR 5093)

07/2004 - Covered costs of transplantation of pancreatic islet cell, but only in context of an NIH-sponsored clinical trial. Effective date 10/01/2004. Implementation date 10/04/2004. (TN 18) (CR 3385)

04/2000 - Corrected ICD-9-CM code from 52.83 to 52.82, and deleted reference to 36-month period of entitlement. Effective and implementation dates 10/01/2000. (TN 124) (CR 1132)

08/1999 - Removed requirement that procedure must be performed simultaneously with or after a Medicare covered kidney transplant. Effective and implementation dates 07/01/1999. (TN 119) (CR 929)

04/1999 - Specified that procedure only covered when performed simultaneously with or after a Medicare covered kidney transplant. Noncoverage of procedure continues for patients who have not experienced end stage renal failure secondary to diabetes. Effective date 07/01/1999. (TN 115) (CR 818)