The Importance of Expanding Medicare Continuous Glucose Monitoring Coverage for High-Risk Hypoglycemia.

Medicare's current coverage policy for continuous glucose monitoring (CGM) restricts their use to people with diabetes. This restriction is based on an older National Coverage Determination (NCD 40.2) that limits blood glucose testing to people with diabetes. The CGM coverage policy also requires that CGM be used only in accordance with an Food and Drug Administration (FDA) indication for its use. However, the law, regulation, and subregulatory guidance do not require such a restriction. Multiple conditions unrelated to diabetes are associated with risk of hypoglycemic events, such as postbariatric and other upper gastrointestinal surgery, glycogen storage diseases, kidney and liver failure, neuroendocrine tumors that secrete insulin, other forms of tumor-associated hyperinsulinism, and autoimmune conditions. To avoid life-threatening hypoglycemic events, these patients need access to CGM to monitor their glucose levels. Thus, the Centers for Medicare & Medicaid Services should rescind NCD 40.2. The durable medical equipment Medicare administrative contractors (MACs) responsible for establishing CGM coverage policy should remove the requirement that CGM be used only in accordance with an FDA indication for its use. This would allow the MACs to extend coverage for CGM to populations at high risk for hypoglycemia, as the evidence supports such an approach.