Budget Impact Analysis of Self-Monitoring of Blood Glucose vs. Flash-Continuous Glucose Monitoring in Intensive Insulin Users with Diabetes Type 2 Covered by Medicare and Medicaid

Abstract

Introduction: Self-Monitoring of Blood Glucose (SMBG) uses capillary blood glucose to measure glycemia in diabetic patients. Recently FDA-approved Flash Continuous Glucose Monitoring (F-CGM) reveals glucose levels when scanned by the reading device. The Centers for Medicare and Medicaid Services (CMS) have announced to reimburse F-CGM at the same level as CGM devices.

Aim: This analysis’ objective was to quantify the CMS budget impact (BI) of F-CGM reimbursement in patients with type 2 diabetes (T2DM) on intensified insulin therapy (IIT), and compare it to the BI of conventional SMBG via cost-related break-even metrics. These were chosen because - in the absence of RCT-based, primary endpoint-driven clinical superiority evidence of F-CGM over SMBG for this population (REPLACE study) - they are well-suited to inform budget allocation decisions.

Methods: An economic model was developed in Excel. CMS reimbursement/patient co-insurance levels for SMBG and F-CGM were used; data on morbidity, treatment and usage patterns were sourced from the literature and official websites. Different scenarios were simulated to elicit break-even points between F-CGM and SMBG.

Results: The annual cost of SMBG with 3.7 tests per day (see REPLACE) is $180 per patient, compared to $2,156 incurred per F-CGM patient, representing a cost difference of $1,976/year or $5.41/day. This implies a budget break-even ratio of 1:12 patients (F-CGM:SMBG). Both technologies would break even at a consumption of 44 test strips per day. A year’s SMBG budget would last only 30 days if spent on F-CGM.

Conclusion: With diabetes budgets under pressure, thoughtful spending policies are needed. It is recommended to analyze in detail which T2DM subgroups will benefit most from F-CGM, focusing reimbursement to the latter. SMBG, being an established technology, represents - at current reimbursement levels - an attractive spending option to budget holders.