July 17, 2014
Coverage and Correct Coding of Continuous Glucose Monitoring Devices
Updated December 18, 2014:
Joint DME MAC Publication
Continuous glucose monitoring (CGM) devices measure glucose in the interstitial fluid, not capillary blood, providing interstitial glucose readings every few minutes. CGM systems are composed of several components - disposable sensors that are inserted in the subcutaneous tissue, a transmitter that relays information to the receiver, and a receiver where the information is displayed.
Current CGM systems are FDA - approved only as a secondary source for glucose monitoring. According to the FDA labeled indications, all CGM device readings must be confirmed with a capillary blood glucose monitor and users are cautioned against making insulin dosage changes based solely on CGM system determinations. Consequently, CGM devices are considered precautionary equipment. The Medicare Durable Medical Equipment Benefit excludes precautionary items from coverage; therefore, claims for CGM systems are denied as statutorily non-covered, no benefit.
Medicare covers necessary supplies used with covered items. When the base item is non-covered, the related supplies are also not covered. Claims for supplies used with CGM systems are denied as statutorily non-covered, no benefit.
CGM systems are provided either as stand-alone systems or integrated into an insulin pump. For stand-alone systems and related supplies, use the following HCPCS codes:
A9276 - SENSOR; INVASIVE (E.G. SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY
A9277 - TRANSMITTER; EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM
A9278 - RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM
CGM capability that is integrated into an insulin pump is considered as included in the coding for the infusion pump. Additional supplies necessary for CGM use are likewise included in the code for the infusion pump supplies. There is no separate or additional coding for CGM functions. The following HCPCS codes are used for insulin pumps and related supplies:
E0784 - EXTERNAL AMBULATORY INFUSION PUMP, INSULIN
A4221 SUPPLIES FOR MAINTENANCE OF DRUG INFUSION CATHETER, PER WEEK (LIST DRUG SEPARATELY)
K0552 - SUPPLIES FOR EXTERNAL DRUG INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH
Separately billing for a CGM system integrated into an infusion pump or related supplies are incorrect. Claims for separate billing will be denied as unbundling.