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National Coverage Determination (NCD) for ISLET CELL Transplantation in the Context of a Clinical Trial (260.3.1)

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Benefit Category
Inpatient Hospital Services
Physicians' Services

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

Item/Service Description

A. General

As a result of section 733 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108-173), The Secretary of the Department of Health and Human Services, acting through the National Institute of Diabetes and Digestive and Kidney Disorders, shall conduct a clinical investigation of pancreatic islet cell transplantation that includes Medicare beneficiaries.

The transplant is performed on patients with Type I diabetes. A typical islet cell transplant requires over 500,000 islet cells, but varies depending on the recipient’s weight. One of the desired patient outcomes is insulin independence. Elimination of clinically significant hypoglycemia episodes and improved glucose control are other important patient outcomes.  One or more pancreata are obtained from donor(s). The islets must be removed within hours after the recovery of the donor pancreas to ensure viability. The islet cells are transplanted by injection into the portal vein of the recipient either using direct visualization, guided ultrasound or percutaneously. The islet cell transplant may be performed alone, in combination with a kidney transplant, or after a kidney transplant.

Islet recipients require immunosuppressant therapy to prevent rejection of the transplanted islet cells. Routine follow-up care is necessary for each trial participant.

Indications and Limitations of Coverage

B. Nationally Covered Indications

Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s). The term 'routine costs' means reasonable and necessary routine patient care costs, including immunosuppressive drugs and other follow-up care, as defined in section 310.1 of the NCD Manual.

Specifically, Medicare will cover transplantation of pancreatic islet cells, the insulin producing cells of the pancreas. Coverage will include the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.

C. Nationally Noncovered Indications

Partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial continues to be noncovered.

D. Other

Not applicable.

(This NCD last reviewed July 2004.)

Transmittal Number


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)

01/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy.Implementation date: 04/01/2013 Effective date: 10/1/2014. (TN 1165) (CR 8109)