This document addresses the use of external insulin pumps, which provide subcutaneous insulin infusion to treat diabetes mellitus.

Note: Some external insulin pump devices come equipped with the capacity to be combined with continuous interstitial glucose monitor (CGM) devices to create automated insulin delivery systems. Devices with such features may be used as stand-alone insulin pumps or as combined systems, depending upon an individual’s need.

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

• CG-DME-42 Continuous Glucose Monitoring Devices
• CG-DME-50 Automated Insulin Delivery Systems
• CG-SURG-79 Implantable Infusion Pumps

Clinical Indications

Medically Necessary:

External insulin pumps (either disposable or durable) are considered medically necessary when the following criteria are met:

1. The individual has documented diabetes mellitus (any type); and
2. The individual or caregiver(s) has completed a comprehensive diabetes education program; and
3. Both of the following criteria are met:
   1. Insulin injections are required multiple times daily; and
   2. Multiple blood glucose tests are required daily or a continuous glucose monitor is being used.

Refills for medically necessary disposable external insulin pumps are considered medically necessary.

Continued use of an external insulin pump (including for individuals who used a continuous insulin infusion pump prior to enrollment with this plan) is considered medically necessary when the device has resulted in clinical benefit (for example, improved or stabilized HbA1c control or fewer episodes of symptomatic hypoglycemia or hyperglycemia).

Replacement pumps:

The replacement of external insulin pumps 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.

Note: The medical necessity of the replacement of an external insulin pump for pediatric individuals (under 18 years of age) who require a larger insulin reservoir will be considered on a case-by-case basis. The following information is required when submitting requests:

1. Current insulin pump reservoir volume; and
2. Current insulin needs; and
3. Current insulin change out frequency required to meet individual needs.

Not Medically Necessary:

The use of an external insulin pump is considered not medically necessary when the criteria above have not been met.

Continued use of an external insulin pump is considered not medically necessary when continued use criteria above have not been met.

Replacement of currently functional and warranted external insulin pumps is considered not medically necessary when the criteria above have not been met, including when the request is to upgrade to a newer pump with additional features.