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.