Invasive Continuous Glucose Monitors
Invasive continuous glucose monitors (A9276, A9277, A9278)(e.g., Continuous Glucose Monitoring System, Guardian CGMS, DexCom STS CGMS) and related supplies are considered medically necessary for long-term use in Type I Diabetes Mellitus patients who have had:

• Recurrent episodes of severe hypoglycemia (defined as blood sugar levels less than 50 mg/dl) despite appropriate modifications in insulin regimen and compliance with frequent self-monitoring of blood glucose (at least 4 fingersticks per day); and
• Require either insulin injections three or more times a day or the use of an insulin pump.

OR

• Documented hypoglycemic unawareness. Documentation of hypoglycemic unawareness could include reports of the short term (72 hour) CGMS and/or the individual patient’s log of self-monitored blood sugars in addition to a completed Hypoglycemia Awareness Questionnaire. (See Text Attachment.) 

Long-term use of invasive continuous glucose monitors and related supplies remains experimental/investigational for all other indications, and is not eligible for reimbursement. A participating, preferred, or network provider can bill the member for the denied device and supplies.

Date Last Reviewed - 06/2008

Non-invasive Continuous Glucose Monitors
Non-invasive continuous glucose monitors (S1030, S1031)(e.g., GlucoWatch) 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.

Date Last Reviewed - 07/2007

Description

Recently, measurements of glucose in interstitial fluid have been developed as a technique of automatically measuring glucose values throughout the day, producing data that show the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional blood glucose measurements. While these devices are intended to potentially eliminate or decrease the number of required daily fingersticks, it should be noted that, according to the FDA labeling, they are not intended to be an alternative to traditional self-monitoring of blood glucose levels but rather serve as an adjunct, supplying additional information on glucose trends that are not available from self-monitoring. It is hoped that this information on glucose trends will lead to improved anti-diabetic regimens and, ultimately, normalization of hemoglobin A1c levels with a decreased risk of hypoglycemia.

Invasive Continuous Glucose Monitors
The Continuous Glucose Monitoring System (CGMS)(MiniMed) and the upgraded version, the Guardian CGMS, consist of a subcutaneously implanted sensor that is attached to a small plastic disk the size of a dime and is taped to the skin to hold the sensor in place. A thin wire connects the sensor to a pager-sized glucose monitor, which records and stores glucose values in memory. An electrical signal is continuously relayed to the glucose sensor, which records glucose levels every 5 minutes, some 288 values per day. For calibration purposes, the manufacturer recommends that the patient enter the results of 4 fingerstick blood glucose measurements per day into the monitor. For the Guardian CGMS, it is recommended that the device be calibrated with fingerstick blood glucose levels every 12 hours at a minimum. The CGMS sensors are capable of transmitting values for up to 3 days, after which time the sensor must be removed and replaced with another by the patient, if additional monitoring is needed. The Guardian CGMS can store up to 21 days of data. The data captured in the monitor can be downloaded to a personal computer for review and used by a physician or the patient. Unlike the GlucoWatch, the glucose values are not displayed on these systems. However, the Guardian CGMS features an audible alarm that sounds when glucose levels become too high or too low per parameters set by the patient and physician. The alarm is intended to prompt the patient to perform a fingerstick blood glucose measurement, since a level is not provided with the sounding of the alarm.

According to FDA labeling, invasive continuous glucose monitoring devices are to be used only as a supplement to, and not a replacement for, standard self-monitoring of blood glucose. They are not intended to change patient management based on the numbers generated but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take the fingerstick glucose measurements to better manage patients.

Subsequently, additional devices have been approved by the FDA that provide real-time continuous glucose monitoring. This includes, but is not limited to, the Guardian-RT (Real-Time) CGMS (Medtronic, MiniMed), and the DexCom STS CGMS system (DexCom).

Non-invasive Continuous Glucose Monitors
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. According to FDA labeling, this device is not 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
12/2008, Invasive continuous glucose monitors eligible for select criteria

Continuous Monitoring of Glucose in the Interstitial Fluid, Medical Policy Reference Manual, Policy 1.01.20

Medicare Report, June 2000, Pg. 61

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

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

Can continuous glucose monitoring provide objective documentation of hypoglycemia unawareness? Endocr Pract. 2005 Mar-Apr;11(2):83-90

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

Glycemic characteristics in continuously monitored patients with type 1 and type 2 diabetes: normative values. Diabetes Care. 2005 Oct;28(10):2361-6

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

Value and limitations of the Continuous Glucose Monitoring System in the management of type 1 diabetes. Diabetes Metab. 2006 Apr;32(2):123-9

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

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

Efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetic patients. Diabetes Res Clin Pract. 2007 Jan;75(1):30-4

A pilot trial in pediatrics with the sensor-augmented pump: combining real-time continuous glucose monitoring with the insulin pump. J Pediatr. 2007 Jan;150(1):103-105

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

Continuous home monitoring of glucose: improved glycemic control with real-life use of continuous glucose sensors in adult subjects with type 1 diabetes. Diabetes Care. 2007 Dec;30(12):3023-5

Please circle only one answer for each question.

1. Have you lost the ability to experience symptoms such as sweating, shaking, palpitations, light-headedness, or nervousness when your blood sugar is low?

   No / Yes

2. To what extent can you recognize low blood sugar based on symptoms?

   Never / Seldom / Sometimes / Often / Always

3. Below which level do you feel that your blood sugar is low?
   
   65 / 60 / 55 / 50 / 45

4. During the past year, did you have any low blood sugar episode associated with confusion for which you required assistance from another person?

   No / Once / More than once

5. During the past year, did you have any low blood sugar episode for which you required intervention from paramedics, an emergency department visit, or an injection of glucagon by another person?

   No / Yes

Diagnosis Codes

For procedure codes A9276, A9277, and A9278, the following diagnosis codes apply:

250.01
250.03
250.11
250.13
250.21
250.23
250.31
250.33
250.41
250.43
250.51
250.53
250.61
250.63
250.71
250.73
250.81
250.83
250.91
250.93