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).