This document addresses automated insulin delivery systems for the management of diabetes mellitus. Automated insulin delivery systems combine insulin pumps and continuous interstitial glucose monitors (CGMs). These devices allow management of blood glucose with little to no input by the user. Such devices come in several configurations, including open-loop, hybrid closed-loop, and fully closed-loop systems.

Note: This document does not address supplies related to the use of automated insulin delivery devices.

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

• CG-DME-42 Continuous Glucose Monitoring Devices
• CG-DME-51 External Insulin Pumps
• CG-SURG-79 Implantable Infusion Pumps

Clinical Indications

Medically Necessary:

Use of an open-loop or hybrid closed-loop automated insulin delivery system is considered medically necessary for individuals who meet the following criteria:

1. Type 1 diabetes mellitus; and
2. Age used in accordance with FDA approval or authorization (for example, age 2 years or older); and
3. HbA1c value of 5.8% to 10%; and
4. Meets the following criteria below for personal long-term use of continuous interstitial glucose monitoring devices:
   1. Insulin injections are required multiple times daily or an insulin pump is used for maintenance of blood sugar control; and
   2. Both of the following (a and b):
      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.

Use of a fully closed-loop device automated insulin delivery system is considered medically necessary for individuals who meet the following criteria:

1. Type 1 diabetes mellitus; and
2. Age used in accordance with FDA approval or authorization (for example, age 6 years or older); and
3. HbA1c value of 5.8 to 10%; and
4. Presence of diabetes for at least 12 months; and
5. Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer; and
6. Meets the following criteria below for personal long-term use of continuous interstitial glucose monitoring devices:
   1. Insulin injections are required multiple times daily or an insulin pump is used for maintenance of blood sugar control; and
   2. Both of the following (a and b):
      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 an open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system 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 previously approved open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system is considered medically necessary when the medically necessary criteria above have previously been met and all of the criteria below have been met:

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

Not Medically Necessary:

Use of an open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system is considered not medically necessary when the criteria above have not been met.

Continued use of an open-loop, hybrid closed-loop, or fully-closed loop automated insulin delivery system is considered not medically necessary when continued use criteria above have not been met.

Replacement of currently functional and warrantied open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system is considered not medically necessary when the replacement criteria above have not been met.

Use of a non-FDA-approved open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system is considered not medically necessary under all circumstances.