National Coverage Analysis (NCA) Tracking Sheet

Insulin Pump: C-Peptide Levels as a Criterion for Use



CMS has covered use of the Continuous Subcutaneous Insulin Infusion Pumps since 2000, based on several criteria that include a certain C-peptide range.  The C-peptide requirement was added after consultation with experts and specialty groups, as a way to ensure that recipients truly had Type 1 diabetes mellitus. At first, the C-peptide level was required to be <0.5 ng/mL, but in January 2002, CMS revised the cut-point for the C-peptide level to less than or equal to 110% of the lower limit of normal of the lab's measurement method.  This change in C-peptide requirement was accompanied by removal of the requirement that patients have Type 1 diabetes.

CMS has viewed C-peptide level as a means of assessing residual beta-cell function by measuring insulin secretory ability and ensuring appropriateness of the infusion pump. We had remaining questions about the precise role of insulin pumps for management of Type II diabetes, and the impact of renal dysfunction on c-peptide values.

We will be reviewing new evidence pertaining to this C-peptide requirement, and perhaps eliminating it or modifying it again.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Medtronic MiniMed, 18000 Devonshire Street, Northridge, CA 9135-1219, View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
04/01/2004 - 05/01/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
09/30/2004 - 10/30/2004
Decision Memo Released


Lead Analysts
CDR Betty Shaw, USPHS
Lead Medical Officers
Lawrence Schott, M.D., M.S.

Medicare Benefit Category Determination Date

Actions Taken

April 1, 2004

Opened formal NCD request and posted tracking sheet on the Internet.

(Comments from this period [PDF, 2MB])

September 30, 2004

CMS is posting a Proposed Decision Memorandum for a 30-day public comment period. CMS is particularly interested in comments on the following:

  • CMS interpretation of the evidence and
  • CMS decision.

  • Instructions for submitting public comments are available at

    November 19, 2004

    Comments from the 30-day public comment period are now available for viewing. [PDF, 109KB]

    December 17, 2004