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National Coverage Determination (NCD)

Pancreas Transplants

260.3

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Tracking Information

Publication Number
100-3
Manual Section Number
260.3
Manual Section Title
Pancreas Transplants
Version Number
2
Effective Date of this Version
10/01/2004
Ending Effective Date of this Version
04/26/2006
Implementation Date
10/04/2004
Implementation QR Modifier Date

Description Information

Benefit Category
Inpatient Hospital Services
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

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.

Medicare has had a long-standing policy of not covering pancreas transplantation, as the safety and effectiveness of the procedure had not been demonstrated. The Office of Health Technology Assessment performed an assessment of pancreas-kidney transplantation in 1994. It found reasonable graft survival outcomes for patients receiving either simultaneous pancreas-kidney transplantation or pancreas-after-kidney transplantation.
Indications and Limitations of Coverage

B. Nationally Covered Indications

CMS determines that whole organ pancreas transplantation will be nationally covered by Medicare only when performed simultaneous with or after a kidney transplant. If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy will begin with the date of discharge from the inpatient stay for the pancreas transplant.

C. Nationally Noncovered Indications

CMS determines that the following procedures are not considered reasonable and necessary within the meaning of section 1862(a)(1)(A) of the Social Security Act:

  1. Pancreas transplantation for diabetic patients who have not experienced end-stage renal failure secondary to diabetes.
  2. Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial (see section 260.3.1 of the NCD Manual)).

D. Other

Not applicable.

(This NCD last reviewed July 2004.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
18
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R18NCD.pdf
Revision History

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)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Pancreas Transplants 3 04/26/2006 - N/A View
Pancreas Transplants 2 10/01/2004 - 04/26/2006 You are here
Pancreas Transplants 1 07/01/1999 - 10/01/2004 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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