Insulin Pump Users

David, Jan-
The entire original section still refers to the <0.5 limit.
However, an updated memo (5/14/01) references that different tests have
different limits so there would be a limit of the normal low reference point
+10% as the maximum allowed. Still confusing though.
Following are some exerpts from the Memo:

Medicare Coverage Policy ~ Decisions
C-Peptide Levels as a Criterion for Use of the Insulin Pump (#CAG-00092A)
Decision Memorandum
SUBJECT: National Coverage Determination (NCD)
DATE: May 14, 2001
This memorandum serves four purposes: (1) outlines the NCD on the continuous
subcutaneous insulin infusion pumps for Type I diabetics [CAG-00041]; (2)
discusses the use of C-peptide as a means to distinguish Type I vs Type II

diabetics; (3) reviews the scientific and clinical literature on the use of
C-peptide levels as a method of determining beta-cell activity; and (4)
delineates the reasons for revising the C-peptide requirement for coverage
of the pump.

Unlike many other laboratory tests, there can be several reference ranges
for C-peptide levels, especially depending upon type of laboratory assay
used, age of patient, and whether or not a patient has fasted prior to the
test. There are two laboratories processes routinely used to quantify
C-peptide.5 These include:
radioimmunoassay (RIA) method and
immunochemiluminometric assay (ICMA) method.

Table 1: Specific age-related reference ranges
for plasma-c-peptide (ICMA method)
Age C-peptide value (ng/mL)
birth - 9 years and 11 months 0.0-0.3
10 years - 16 years and 11 months 0.4-3.3
17 years and up 0.9 - 4

C-peptide levels may also vary depending upon stage of the disease.
According to the Expert Committee on the Diagnosis and Classification of
Diabetes Mellitus, those patients with immune-mediated diabetes "eventually
become dependent on insulin for survival and are at risk for ketoacidosis.
At this latter stage of the disease, there is little or no insulin, as
manifested by low or undetectable levels of plasma C-peptide."

DECISION:
Revise Coverage Issues Manual 60-14, so that:
Adjust Fasting C-peptide requirement such that the value must be less than
or equal to, the lower limit of normal of the lab’s measurement method, +
10%.
Remove the Type I requirement, to include Type II diabetics as long as they
meet all other requirements, including fasting C-peptide requirement, as
noted above.

Marj

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