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National Coverage Analysis (NCA) Tracking Sheet

Pancreas Transplants

CAG-00295R

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Issue

Medicare covers whole organ pancreas transplantation when it is performed in conjunction with or after kidney transplantation (National Coverage Determination (NCD) Manual section 260.3). However, Medicare does not cover pancreas transplantation alone (PA) in diabetes patients without end-stage renal failure due to a lack of sufficient evidence based in large part on a 1994 Office of Health Technology Assessment report.

On July 1, 2005 the Departmental Appeals Board issued a ruling that the current record was not complete and adequate to support the validity of the provision excluding Medicare coverage of all PA procedures. The ruling did not address whether the current NCD is valid under the reasonableness standard. Based on the Board's recent ruling, CMS is opening an NCD to determine whether PA is reasonable and necessary.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services

Requestor Information

Requestor Name Requestor Letter
NA N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/29/2005
Expected NCA Completion Date
04/26/2006
Public Comment Period
07/29/2005 - 08/29/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
01/26/2006
Proposed Decision Memo Public Comment Period
01/26/2006 - 02/26/2006
Decision Memo Released
04/26/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Susan Harrison
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

July 29, 2005

CMS is requesting public comments.

January 26, 2006

CMS is requesting public comments on this proposed decision memorandum pursuant to Section 731 of the Medicare Modernization Act. CMS encourages public comment on this proposed decision through our website http://www.cms.hhs.gov/Center/Special-Topic/Medicare-Coverage-Center.html. We are particularly interested in comments that include evidence in addition to commentary. We are particularly interested in evidence that compares outcomes of patients with type 1 diabetes without kidney failure who undergo PA to similar patients with type 1 diabetes who are treated without transplantation. Also of interest is the maximum stage of kidney insufficiency permissible for a patient to receive a PA. During our review of the medical literature and various health plan policies, a wide range of kidney insufficiency (usually reported using the creatinine clearance) was found in the eligibility criteria for a PA. We will consider these comments and any new evidence prior to releasing our final decision.

April 26, 2006

CMS posts final decision.
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