Table 1.
Recommendations for Modifying Medicare CGM Eligibility Requirements. 26
| Criterion | Supporting evidence |
|---|---|
| 1. Diagnosed with T1D. |
CGM use confers: • Significant reductions in HbA1c.15,17,28 -36 • Significant reductions in severe hypoglycemia events.18,32,33,37 • Significant increases in %TIR.17,20,30,36,38 • Significant decreases in %TBR.17,30,36 • Significant reductions in diabetes-related hospitalizations.18,32,33,39 |
| 2. Diagnosed with T2D and treated with any insulin therapy. |
CGM use confers: • Significant reductions in HbA1c.29,31,40 -47 • Significant increases in %TIR.29,40,47 • Significant decreases in %TBR.19,48 • Significant decreases in %TAR. 47 • Significant reductions in severe hypoglycemia events. 37 • Significant reductions in diabetes-related hospitalizations.39,49 |
| 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: • Level 2 (moderate) hypoglycemia—characterized by glucose levels ≤ 54 mg/dL. • Level 3 (severe) hypoglycemia—characterized by physical/mental dysfunction requiring third-party assistance. Nocturnal hypoglycemia. |
Older diabetes patients are at increased hypoglycemia risk: • T2D patients treated with antihyperglycemic medications (eg, insulin and sulfonylureas) are at higher risk for hypoglycemia than those treated with non-hypoglycemia medications (eg, metformin). 50 • T2D patients ≥65 years treated with basal insulin (typically one injection per day) are at increased risk for severe hypoglycemia. 51 • A key driver of hypoglycemia risk is impaired hypoglycemia awareness.52,53 CGM use confers: • Significant reductions in diabetes-related hospitalizations, including severe hypoglycemia events.39,49 • Significant reductions in severe hypoglycemia events. 37 • Significant reductions in hypoglycemia fear and increases in patient confidence in avoiding/treating hypoglycemia,28,54 thereby supporting treatment adherence.55,56 |
| 4. Chronic kidney disease (CKD). |
CGM use facilitates: • More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia. 57 • Effective monitoring and managing glycemic levels in patients without diabetes with ESRD undergoing dialysis. 58 |
| 5. In-person or telemedicine consultation with the prescribing healthcare provider prior to CGM initiation and every 6 months thereafter while continuing CGM therapy. |
Use of telemedicine consults: • Significantly reduces HbA1c.59 -64 • Reduces the incidence of severe hypoglycemic events. 63 • Significantly reduces diabetes-related distress. 65 • Significantly improves medication adherence. 66 • Effectively addresses the obstacles caused by the COVID-19 pandemic.67 -71 • Are more effective for patients who are residents of cities and using the websites as their intervention method. 61 Use of downloaded CGM data into standardized reports: • Supports patient education. 72 • Enhances patient engagement in their self-management. 72 |
Abbreviations: CGM, continuous glucose monitoring; %TIR, percentage time in range; %TBR, percentage time below range; HbA1c, glycated hemoglobin; %TAR, percentage time above range; ESRD, end-stage renal disease.