National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00092N

Issue

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 Name Requestor Letter
Internal N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/01/2001
Expected NCA Completion Date
05/01/2001
Public Comment Period
03/05/2001 - 04/05/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
05/11/2001

Contacts

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

Medicare Benefit Category Determination Date

Actions Taken

May 11, 2001

Decision made.