Continuous glucose monitors (A9276, A9277, A9278, S1030, S1031)(Non-invasive [e.g., GlucoWatch], Invasive [e.g., the Continuous Glucose Monitoring System (CGMS), MiniMed]) and related supplies are considered experimental/investigational, and are not eligible for reimbursement. Despite the fact that these devices have received FDA approval, there is a lack of long-term studies demonstrating that the use of these devices is associated with an improvement in final health outcomes, i.e., improved diabetic control based either on decreasing hemoglobin A1c values and/or decreasing incidence of hypoglycemia. A participating, preferred, or network provider can bill the member for the denied device and supplies.

The GlucoWatch is similar in appearance to a wristwatch. It is worn on the inner or outer surface of the forearm. The AutoSensor, a single-use disposable component, consists of a gel collection disc and a series of electrodes. The AutoSensor snaps into the back of the GlucoWatch and adheres to the skin. This non-invasive device measures glucose in interstitial fluid extracted through the skin with an electric current (referred to as reverse iontophoresis). It automatically measures glucose as frequently as every 10 minutes for up to a 13-hour period. After 13 hours, the AutoSensor needs to be replaced. The GlucoWatch displays the most recent glucose level and can store as many as 8,500 glucose readings along with their date and time. An audible alarm will sound if any reading is above a preset high or preset low level or if the glucose reading is declining rapidly. Each day prior to use, the device must be calibrated with a finger stick glucose test to allow for variability in skin permeability among individuals and at different skin sites. Specifically, it is recommended that changes in medication should not be prompted solely by a GlucoWatch measurement, but confirmed by a fingerstick blood glucose measurement. In addition, as noted above, fingersticks are required to calibrate the device each day.
 
The Continuous Glucose Monitoring System (CGMS) consists of a subcutaneous glucose sensor and a small, pager-type monitor. The glucose sensor is inserted into the patient’s subcutaneous tissue, typically in the abdominal area, and is usually worn for a period of 24 to 72 hours. The sensor measures glucose levels every 10 seconds, and is capable of transmitting values for up to three days, after which time it must be replaced if additional monitoring is needed. The battery-operated monitor averages glucose measurements every five minutes, providing 288 glucose readings over a 24-hour period. Glucose data and event information entered manually by the patient are stored in the monitor. Health care professionals can download data from the monitor to a personal computer for retrospective analysis. The CGMS is intended for occasional rather than everyday use.

According to FDA labeling, neither device is intended to be an alternative to traditional self-monitoring of blood glucose levels, but rather serve as an adjunct.

Coverage for durable medical equipment is determined according to individual or group customer benefits.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA- approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition. The GlucoWatch and Continuous Glucose Monitoring System are considered eligible services when determined medically necessary based on the patient's condition.

PRN References

10/2003, Continuous glucose monitors considered investigational

Continuous Monitoring of Glucose in the Interstitial Fluid, Medical Policy Reference Manual, Policy 1.01.20, 11/09/2004

National Blue Cross Blue Shield Association TEC Assessment, Vol. 18, No. 16, December 2003

Medicare Report, June 2000, Pg. 61

The accuracy of the GlucoWatch G2 biographer in children with type 1 diabetes: Results of the diabetes research in children network (DirecNet) accuracy study, Diabetes Technol Ther, 2003; 5(5):791-800

Use of the GlucoWatch biographer in children with type 1 diabetes, Pediatrics, 2003 Apr; 111(4 Pt 1):790-4

Use of the Cygnus GlucoWatch biographer at a diabetes camp, Pediatrics, 2004 Jan; 113(1 Pt 1):108-11

Glucose sensors: Toward closed loop insulin delivery, Endocrinol Metab Clin North Am,01-MAR-2004; 33(1): 175-95, xi

The role of continuous glucose sensors in diabetes care, Endocrinol Metab Clin North Am, 2004 Mar; 33(1):163-73, x-xi.

Accuracy of the GlucoWatch G2 Biographer and the continuous glucose monitoring system during hypoglycemia: Experience of the Diabetes Research in Children Network, Diabetes Care, 2004 Mar; 27(3):722-6

Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: Results of the Diabetes Research in Children Network (DirecNet) accuracy study, J Pediatr, 01-JUN-2004; 144(6): 770-5

Use of the noninvasive GlucoWatch Biographer during exercise of varying intensity, Diabetes Technol Ther, 2004 Aug; 6(4):454-62

Rates of glucose change measured by blood glucose meter and the GlucoWatch Biographer during day, night, and around mealtimes, Diabetes Care, 2004 Sep; 27(9):2161-5

GlucoWatch G2 Biographer alarm reliability during hypoglycemia in children, Diabetes Technol Ther, 2004 Oct; 6(5):559-66

Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: A randomized controlled trial, Mayo Clin Proc. 2004 Dec;79(12):1521-6

Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: Results from a diabetes research in children network (DirecNet) study, Diabetes Technol Ther, 2005 Feb; 7(1):109-14

Self-monitoring of blood glucose in children and teens with diabetes, Pediatr Diabetes, 01-MAR-2005; 6(1): 50-62

Home use of the GlucoWatch G2 biographer in children with diabetes, Pediatrics, 2005 Mar; 115 (3):662-6

A randomized multicenter trial comparing the GlucoWatch Biographer with standard glucose monitoring in children with type 1 diabetes, Diabetes Care, 2005 May; 28(5):1101-6

Eight-point glucose testing versus the continuous glucose monitoring system in evaluation of glycemic control in type 1 diabetes, J Clin Endocrinol Metab, 01-JUN-2005; 90(6): 3387-91

Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: A single-blind, randomized, controlled trial. Pediatric Diabetes,  01-JUN-2006; 7(3): 159-64

Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: A randomized controlled trial. Diabetes Care, 01-JAN-2006; 29(1): 44-50

Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care, 01-DEC-2006; 29(12): 2730-2

Continuous Blood Glucose Monitoring Shows No Effect on Long-Term Glucose Control, American Diabetes Association 67th Scientific Sessions: Abstract 0115-OR. Presented June 23, 2007

Continuous glucose monitoring versus self-monitoring of blood glucose in the treatment of gestational diabetes mellitus. Diabetes Research and Clinical Practice,  01-AUG-2007; 77(2): 174-9