National Coverage Analysis (NCA) Tracking Sheet

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



On August 25, 1999 HCFA issued a National Coverage Decision for the Use of the Continuous Subcutaneous Insulin Infusion Pumps. (CAG-00041).

One of the criteria for coverage was a C-peptide level <0.5 This requirement was added after consultation with various experts and specialty groups, as a way to ensure that patients were truly Type1 diabetics. Theoretically, patients with Type I diabetes should have an undetectable C-peptide level.

Within the past 12 months, we have heard from numerous beneficiaries who are Type I diabetics and who would otherwise meet the criteria except for a C-peptide level slightly above 0.5 We are interested in reviewing this requirement, and perhaps revising this cutoff point.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor NameRequestor Letter
Internal N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
03/05/2001 - 04/05/2001
Decision Memo Released


Lead Analysts
Betty Shaw
Sharon Hippler
Lead Medical Officers
Mitch Burken, MD

Actions Taken

May 11, 2001

Decision made.