Anthem Blue Cross Connecticut CG-DME-42 Continuous Glucose Monitoring Devices Form

This document addresses the use of continuous glucose monitoring devices (CGMs, also referred to as continuous interstitial glucose monitoring devices) for the management of diabetes mellitus.

CGMs are devices that continuously measure glucose concentrations in the interstitial space of the skin, allowing for indirect blood glucose measurements and avoidance of some or all fingersticks to access capillary blood.  CGMs have been shown to assist in the management of some individuals with diabetes mellitus. Such devices come in a variety of configurations, including “flash” devices allowing on-demand measurements and devices that provide a continuous display of readings.

Note: For additional information regarding diabetes care, please see:

• CG-DME-50 Automated Insulin Delivery Systems
• CG-DME-51 External Insulin Pumps
• CG-SURG-79 Implantable Infusion Pumps

Clinical Indications

Medically Necessary:

I. Non-Implanted Continuous Interstitial Glucose Monitoring Devices for Personal Use

Use of a non-implanted continuous interstitial glucose monitoring device for personal use is considered medically necessary for individuals who meet the following criteria:

1. Individual has been diagnosed with diabetes mellitus (any type); and
2. Insulin injections are required multiple times daily or an insulin pump is used for maintenance of blood sugar control; and
3. Both of the following (1 and 2):
   1. The individual or caregiver(s) demonstrates the following:
      1. An understanding of the technology, including use of the device to recognize alerts and alarms; and
      2. Motivation to use the device correctly and consistently; and
      3. Continued participation in a comprehensive diabetes treatment plan;
         and
   2. Any of the following are present, despite multiple alterations in self-monitoring and insulin administration regimens to optimize care:
      1. Inadequate glycemic control, demonstrated by HbA1c measurements above target; or
      2. Persistent fasting hyperglycemia; or
      3. Recurring episodes of hypoglycemia (blood glucose <50 ml/dL); or
      4. Hypoglycemia unawareness that puts the individual or others at risk; or
      5. In children and adolescents with type 1 diabetes who have achieved HbA1c levels below 7.0%, when treatment is intended to maintain target HbA1c levels and limit the risk of hypoglycemia.

Continued use of a non-implanted continuous interstitial glucose monitoring device for personal use is considered medically necessary when there is documentation that the device has resulted in clinical benefit (for example, improved or stabilized HbA1c control or fewer episodes of symptomatic hypoglycemia or hyperglycemia).

Replacement of a non-implanted continuous interstitial glucose monitoring device for personal use is considered medically necessary when the following criteria have been met:

1. The device is out of warranty; and
2. The device is malfunctioning; and
3. The device cannot be refurbished.

II. Implanted Continuous Interstitial Glucose Monitoring Devices for Personal Use

Use of an implanted continuous interstitial glucose monitoring device for personal use is considered medically necessary when the criteria below have been met:

1. The individual is 18 years of age or older; and
2. The individual meets the medical necessity criteria above for a non-implanted continuous interstitial glucose monitoring device for personal use.

Continued use of an implanted continuous interstitial glucose monitoring device for personal use is considered medically necessary when there is documentation that the device has resulted in clinical benefit (for example, improved or stabilized HbA1c control or fewer episodes of symptomatic hypoglycemia or hyperglycemia).

Replacement of an implantable continuous interstitial glucose monitoring device for personal use is considered medically necessary in accordance with FDA approved indications for use.

III. Professional, Intermittent, Short-Term Continuous Interstitial Glucose Monitoring Devices

Use of a continuous interstitial glucose monitoring device for professional, intermittent, short-term use is considered medically necessary when all of the following criteria are met:

1. Individual meets medically necessary criteria for a non-implanted continuous interstitial glucose monitoring devices above; and
2. Monitoring and interpretation are under the supervision of a physician; and
3. The device is only used for a maximum of 14 consecutive days on an appropriate, periodic basis.

Not Medically Necessary:

Use of continuous interstitial glucose monitoring devices is considered not medically necessary when the criteria above have not been met.

Continued use of a continuous interstitial glucose monitoring device is considered not medically necessary when continued use criteria above have not been met.

Replacement of currently functional and warrantied continuous interstitial glucose monitoring devices is considered not medically necessary when the replacement criteria above have not been met.