Effective January 1, 2014, IBC?s medical policy on interstitial continuous glucose monitoring systems (CGMS) has been updated to include billing requirements for the low-threshold suspend artificial pancreas device system (APDS) (e.g., MiniMed^® 530G System), which is not covered by IBC.

About interstitial CGMSs and APDSs

Interstitial CGMSs are minimally invasive devices that record interstitial glucose levels every one to five minutes. In contrast to traditional self-monitoring of blood glucose, a CGMS automatically measures interstitial glucose levels and uses this data to reveal trends in glucose measurement. CGMSs also use an alarm to alert the individual when sudden or potentially harmful changes in blood sugar levels occur. An APDS, or an artificial pancreas, is emerging technology that combines two devices approved by the U.S. Food and Drug Administration (FDA), CGMSs and insulin pumps, and links them to an APDS Control algorithm. The ultimate goal of the APDS is to monitor glucose levels and automatically adjust insulin levels. These systems are called closed-loop systems, or autonomous systems, for glucose control. There are currently no APDSs approved for use by the FDA. One technology associated with closed-loop artificial pancreas development is a low-glucose suspend (LGS) feature. The LGS feature is designed to suspend insulin delivery when plasma glucose levels fall below a prespecified threshold. On September 26, 2013, the FDA approved the MiniMed 530G System (Medtronic, Inc., CA), a threshold-suspend APDS. Although the FDA has approved the MiniMed 530G System, IBC has determined that its safety and/ or effectiveness cannot be established by review of the available published peer-reviewed literature. APDSs, including LGS technology, are considered experimental/investigational by IBC and are therefore not covered. HCPCS code A9279 (monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components, and electronics, not otherwise classified) shall be used to represent the MiniMed 530G System, which is not covered by IBC. Providers must not combine codes that separately correspond to the insulin pump and continuous glucose monitor to represent an APDS, including those with an LGS feature. Visit the IBC Medical Policy Portal to review Medical Policy #05.00.24j: Interstitial Continuous Glucose Monitoring Systems (CGMSs).