National Coverage Analysis (NCA) Tracking Sheet

Intestinal and Multi-visceral Transplantation

CAG-00036R

Issue

CMS provides coverage for intestinal and multi-visceral transplantation for the purpose of restoring intestinal function in patients with irreversible intestinal failure. This procedure is covered only when performed for patients who have failed total parenteral nutrition (TPN) and only when performed in centers that meet approval criteria. Specifically, the criteria for approval of a center is based on a volume of 10 intestinal transplants per year with a 1-year actuarial survival of 65 percent using the Kaplan-Meier technique (National Coverage Determination (NCD) Manual section 260.5).

On October 29, 2004, CMS received a formal request for reconsideration from the University of Wisconsin Medical School. The University proposed that CMS revise its NCD permit centers that have performed 10 cumulative intestinal transplants with one year patient survival of 65% using the Kaplan-Meier technique to be eligible for Medicare coverage for intestinal and multi-visceral transplantation.

On February 4, 2005 CMS released a proposed rule for requirements for approval and re-approval of transplant centers. The rule does not propose any volume or outcome requirements for intestinal transplants. On August 2, 2005 CMS received a letter from the University of Wisconsin indicating that the proposed rule may not be promulgated for up to two years. Subsequently, they request that CMS reconsider their formal Request for Reconsideration submitted in October. CMS is opening an NCD to reconsider the approval criteria for intestinal and multi-visceral transplant centers.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
University of Wisconsin Medical School View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/11/2005
Expected NCA Completion Date
05/11/2006
Public Comment Period
08/11/2005 - 09/11/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/10/2006
Proposed Decision Memo Public Comment Period
02/10/2006 - 03/12/2006
Decision Memo Released
05/11/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Susan Harrison
Lead Medical Officers
Joseph Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

August 11, 2005

CMS is requesting public comments pursuant to Section 731 of the Medicare Modernization Act. After considering the public comments, we will release a proposed decision memorandum.

February 10, 2006

CMS is requesting public comments on this proposed decision.

May 11, 2006

Final Decision  posted.