Retired - Coverage and Correct Coding of Continuous Glucose Monitoring (CGM) Devices - Revised

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 complete stand-alone systems or with one or more components integrated into an external insulin infusion 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

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

Billing

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have received multiple inquiries regarding correct coding for integrated products with multiple functions, each with a separate HCPCS code.

For CGM capability that is integrated into an insulin pump, the receiver/monitor (A9278) is considered as included in the coding for the infusion pump. There is no separate or additional coding for the integrated CGM receiver/monitor. Claims for separate billing will be denied as unbundling.

For CGM capability integrated into an external insulin infusion pump, the transmitter and supplies for CGM use are separately billable.  Supplies are billed using code A9276. Code A9277 should be used for the non-integrated transmitter. Claims for CGM supplies and non-integrated system components will be denied as statutorily non-covered, no benefit.

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/