Retired - Coverage and Correct Coding of Continuous Glucose Monitoring Devices

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.    

COVERAGE

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.

CODING

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 is incorrect.  Claims for separate billing will be denied as unbundling.

Refer to the LCDs and related Policy Articles for Glucose Monitors and External Infusion Pumps for additional information.

For questions about correct coding, contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form located on the PDAC website: https://www.dmepdac.com/