National Coverage Analysis (NCA) Tracking Sheet

Intestinal and Multivisceral Transplantation

CAG-00036N

Issue

Intestinal and multivisceral transplantation is a procedure where the intestines of a patient are replaced with those from another body. Multivisceral transplantation is transplantation of two or more intestinal organs, such as liver and intestinal transplantation. Medicare contractors have discretion as to coverage of the procedure. Physicians from the Thomas E. Starzl Transplantation Institute have requested a favorable national coverage decision regarding these procedures.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Thomas E. Starzl Transplantation Institute N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/29/1999
Expected NCA Completion Date
10/01/2000
Public Comment Period
07/29/1999 - 08/27/1999
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
10/04/2000

Contacts

Lead Analysts
Jackie Sheridan-Moore
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

August 6, 1999

Letter sent accepting formal request.

September 28, 1999

Technology assessment requested for more literature.

September 28, 1999

Requestor notified of request for assessment.

April 17, 2000

Received Technology assessment

May 5, 2000

Based on review of the technology assessment, a number of issues remain for clarification. In that regard, we are asking all interested parties to respond to the question noted below, with particular regard to the evidence they can provide in support of their responses.

Questions in need of additional evidence:

What clinical manifestations define "failed total parenteral nutrition (TPN)" and what literature is available to support this definition?

Is there scientific evidence to support coverage of small bowel and multivisceral transplantation in the age 65 and older population?

Scientific evidence considered in the assessment is based primarily on the experience in two hospitals. Is there evidence to expand Medicare coverage to this procedure in other facilities?

Is there scientific evidence to support specific facility criteria (similar to Medicare coverage of liver, heart and lung transplants) that should be met prior to Medicare coverage of transplants in that facility?

Is there scientific evidence to support small bowel and multivisceral transplantation in patients with malignant disease and if so, what types of malignant disorders?

Awaiting answers.

June 15, 2000

Received additional information from requester in response to questions. Extended due date.

September 8, 2000

Due to the complexity of the issue, we will need a few extra weeks to complete our review. We are extending the due date on this topic until October 1, 2000.

October 4, 2000

Posted to the web a Decision Memorandum that would provide for coverage of intestinal transplantation to patients who have failed TPN in facilities that meet specified criteria.