Description

Continuous Glucose Monitoring Systems Continuous glucose monitoring systems (CGMS) are devices that measure glucose levels in interstitial fluid at programmable intervals. These readings help detect any patterns or trends with an individual’s glucose levels to help improve diabetes management. The majority of the US Food & Drug Administration (FDA) approved CGMS are intended to assist in calculating the insulin dosage needed to manage glycemic control. CGMS readings may also be used as an adjunct to or replacement for fingersticks.

Description

CGMS use sensors that are inserted under the skin in either the abdomen or upper arm and work by extracting glucose from the interstitial fluid, measuring and recording the glucose level and converting these measurements into equivalent blood glucose readings.

Sensors are designed to be worn three days to two weeks, depending on the product. Calibration is often required whenever a new glucose sensor is inserted, which in most devices, requires obtaining blood glucose from a traditional fingerstick sample.

Professional Diagnostic/Short Term CGMS

Professional CGMS are owned by healthcare providers and are loaned to an individual to use over a short period of time (usually a few days to 2 weeks) to record and store glucose data. Some systems allow for data to be downloaded to a personal computer (PC). The individual returns to the physician’s office where the data can be analyzed and used to prescribe an appropriate insulin regimen. Examples of professional diagnostic/short term CGMS include, but may not be limited to:

• Dexcom G6 Pro: Integrated CGM (iCGM) is FDA-approved for individuals 2 years of age and older. Incorporates a sensor, transmitter and a mobile application (app) and allows glucose to be monitored every 5 minutes. The transmitter can be used as a retrospective CGM data logger and can also send real-time estimated glucose values to the G6 mobile application. The healthcare provider selects which type of CGM session the patient receives (retrospective vs. real- time). The transmitter supports a single-use 10-day sensor session per transmitter.
• FreeStyle Libre Pro: FDA-approved for individuals 18 years of age and older. Indicated for detecting trends and tracking patterns. The sensor is attached to the back of the upper arm; a water-resistant adhesive pad holds the sensor in place and a 5 mm long filament inserted under the skin monitors blood glucose every 15 minutes for a total of 1340 glucose measurements in 14 days.
• iPro2 Professional: The system is used as a diagnostic tool to evaluate glucose levels up to 6 days and provides continuous measurements of the interstitial glucose levels that range from 40 to 400 mg/dl. The glucose sensor signal is acquired every 10 seconds and an average of the acquired signals is saved in memory every 5 minutes.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Personal/Long-term CGMS

Personal CGMS are owned by individuals and provide real-time glucose values that allow users to track patterns and possibly identify episodes of low and high blood glucose levels. The data can be downloaded to PC software and stored for historical analysis. The system will purportedly alert the user if a glucose level falls below or rises above a preset value.

Examples of personal/long-term CGMS include, but may not be limited to:

• Dexcom G6: Integrated CGM (iCGM) is FDA-approved for individuals 2 years of age and older. It is designed to replace blood glucose testing for diabetes treatment decisions and can be used with automated insulin dosing (AID) systems, insulin pumps, blood glucose meters and other electronic devices used for diabetes management. The sensor, which must be replaced every 10 days, also transmits blood glucose values to a compatible viewing device every 5 minutes. No calibration with fingersticks is required for the sensor and an alarm warns of potential hypoglycemia and hyperglycemia.
• Dexcom G7: Integrated CGM (iCGM) is FDA-approved for individuals 2 years of age and older. It is designed to replace blood glucose testing for diabetes treatment decisions and can be used with automated insulin dosing (AID) systems, insulin pumps, blood glucose meters and other electronic devices used for diabetes management. The sensor and transmitter must be replaced every 10 days with a 12 hour grace period. Blood glucose values are transmitted to a compatible viewing device every 5 minutes. No calibration with fingersticks is required for the sensor and an alarm warns of potential hypoglycemia and hyperglycemia.
• FreeStyle Libre 14 Day Flash/FreeStyle Libre Flash: FDA-approved for individuals 18 years of age and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The disposable sensor can be worn for up to 14 days following the initial 1 hour warm-up period. The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time.
• FreeStyle Libre 2 Flash: Integrated CGM (iCGM) is FDA-approved for individuals 2 years of age and older. It is designed to replace blood glucose testing for diabetes treatment decisions. Provides measurements every minute of glucose levels, trends and alerts. The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. The system consists of two primary components: a disposable sensor, which transmits via Bluetooth Low Energy (BLE) and can be worn for up to 14 days, and a BLE enabled display device (reader). The system is also intended to communicate with digitally connected devices, including automated insulin dosing (AID) systems. The system can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
• FreeStyle Libre 3: Integrated CGM (iCGM) is FDA-approved for individuals 2 years of age and older.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 4 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

It is designed to replace blood glucose testing for diabetes treatment decisions. Provides measurements every minute of glucose levels, trends and alerts. The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. The system consists of two primary components: a disposable sensor, which transmits via Bluetooth Low Energy (BLE) and can be worn for up to 14 days, and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running iOS operating system. The system is also intended to communicate with digitally connected devices, including automated insulin dosing (AID) systems. The system can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

• Guardian Connect: FDA-approved for individuals 14 years of age and older. It is used as an adjunctive device to complement, not replace, blood glucose testing for diabetes treatment decisions. The system consists primarily of a sensor, transmitter and mobile medical app designed to provide continuous glucose monitoring for up to 7 days. The CGMS device uses a glucose sensor connected to a transmitter that sends glucose readings every 5 minutes and displays the values through the Guardian Connect app installed on a compatible mobile device. Allows users to detect trends and track patterns in glucose concentrations.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 5 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Guardian REAL-Time: FDA-approved for individuals 7 years of age and older. It is used as an adjunctive device to complement, not replace, blood glucose testing for diabetes treatment decisions. Device uses a glucose sensor connected to a transmitter that sends glucose readings every 5 minutes to a monitor. The glucose sensor is typically discarded and replaced after 3 days. Unique features include predictive and rate of change alarms and expanded trend graphs. Graphs can show the effect of exercise, diet and lifestyle, as well as medication on glucose values using 3, 6, 12 and 24-hour increments. Alarms signal high and low glucose alerts and warn individuals of any significant changes in glucose levels. Data is downloaded using the Medtronic Carelink Therapy Management Software.
• Implantable Interstitial Glucose Sensors Intended for long-term use (90-180 days), the sensor is implanted subcutaneously in the upper arm to measure glucose in the interstitial fluid. The measurement is then relayed to the smart transmitter. The measurement and display of glucose values is done automatically without the need for user intervention.The CGMS provides real-time glucose values in the interstitial fluid, glucose trends and alerts for high and low glucose through a mobile medical application (MMA). The Eversense system consists of a glucose sensor, which can be worn for up to 90-180 days, that is inserted under the skin by a physician; an externally worn transmitter; and the MMA, which runs on a compatible mobile device. The inserted sensor collects readings and sends them to the transmitter. The transmitter calculates, stores and transmits the glucose data to the MMA on the mobile device.

Insulin Pumps

Insulin pumps are devices used to deliver insulin in a programmed and controlled manner to diabetic individuals. These devices work with a separate glucometer through manual or remote functions.

The goal of insulin pump therapy is to achieve near normal control of blood glucose levels. Insulin pumps are categorized as follows:

External insulin pumps

Insulin is delivered via subcutaneous or intraperitoneal routes. External insulin pumps may be either disposable or have disposable components. Examples of FDA-approved external insulin pumps include, but may not be limited to:

• ACCU-CHEK Spirit Combo Insulin Pump: Nondisposable insulin pump with programmable reminders for basal and bolus delivery of insulin. Bluetooth capable for two-way wireless communication with the Aviva combo meter to deliver insulin and adjust pump settings remotely.
• CeQur Simplicity: Disposable, nonelectric device intended for subcutaneous, on-demand bolus dosing around mealtimes. The device does not replace the need for basal insulin and is not intended for the delivery of basal insulin. The unit is applied to the skin and can be worn for up to 3 days.
• Tandem Diabetes Care's t:slim X2 and Basal-IQ technology integrates a basal-bolus insulin pump with a CGMS that includes predictive technology to help prevent hypoglycemia.
• OmniPod DASH System: Combines a tubeless, waterproof insulin pump with a wearable POD that integrates the insulin reservoir and automated cannula insertion system along with the system’s accompanying Personal Diabetes Manager (PDM). The PDM houses a built-in BG meter and tracks both insulin delivery and blood glucose readings within one system.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 6 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Implantable insulin pumps

Surgically implanted rather than worn externally to deliver insulin via intraperitoneal or intravenous routes. Currently there are not any devices that have received FDA-approval for use outside of a clinical trial. (Refer to Coverage Limitations section)

Combined External Insulin Pumps with CGMS

A device that integrates an insulin pump with real-time continuous glucose monitoring as an adjunct to or replacement for fingersticks. These systems incorporate features including predictive alerts that give early warnings so action can be taken to prevent dangerous high or low blood glucose events. Examples of FDA-approved combined external insulin pumps with CGMS include:

• MiniMed Paradigm REAL-Time Revel System: FDA-approved for individuals 7 years of age and older. Device works with the mySentry remote monitoring system:
  • The mySentry remote monitoring system is an optional monitoring device for the MiniMed Paradigm REAL-Time Revel System. The mySentry consists of a remote outpost and monitor. Blood glucose levels collected by the CGM are sent to the remote (wireless) monitor, which also has alarms to alert the user of high or low blood glucose levels. (Refer to Coverage Limitations section)
• t:slim X2 Insulin Pump: FDA-approved for individuals 6 years of age and older. Intended for the subcutaneous delivery of insulin, at set and variable rates.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 7 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The pump can be used solely for continuous insulin delivery, or in addition with the G6 mobile sensor and transmitter (t:slim X2 Insulin Pump with Basal-IQ technology) which features a Bluetooth radio and is designed to receive remote software updates or with an alternate controller enabled (ACE) insulin pump (t:slim X2 Insulin Pump with interoperable technology) which features the ability to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices.

Combined External Insulin Pumps and CGMS with Suspend on Low Feature

Suspend on low is the first step towards an artificial pancreas device system (APDS). This technology combines CGMS with an insulin pump which allows the user to set a low blood sugar threshold value. When the CGM sensor detects the preset low glucose threshold, insulin delivery is suspended. Examples of this type of device includes, but may not be limited to:

• MiniMed 530G System: FDA-approved for individuals 16 years of age and older. Intended for automatic, continuous delivery of basal insulin (at user selectable rates) and manual administration of insulin boluses (in user selectable amounts) requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. This device has SmartGuard technology which automatically stops insulin delivery (for up to 2 hours) when sensor glucose values reach a preset level and when the individual does not respond to the suspend on low alarm.
• MiniMed Connect: (compatible with MiniMed 530G with Enlite and MiniMed Paradigm Revel insulin pump) is an optional wireless device used to access continuous glucose monitor sensor data. Information can be viewed using an internet application through a smart device or via a browser accessible website and can be shared as needed. (Refer to Coverage Limitations section)
• MiniMed 630G: FDA-approved for individuals 16 years of age and older. Intended for automatic, continuous delivery of basal insulin (at user selectable rates) and manual administration of insulin boluses (in user selectable amounts) requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G system includes SmartGuard which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed 630G system with SmartGuard consists of the following devices: MiniMed 630G insulin pump, Enlite sensor, One-Press serter, Guardian Link transmitter system, CareLink USB and Contour NEXT Link 2.4 wireless glucose meter.

Hybrid Closed Loop System

Along with the suspend on low feature mentioned above, these systems have a suspend before low feature that purportedly stops insulin delivery when the sensor is predicted to reach a low limit and resumes after sensor glucose levels recover. Examples of this type of device includes, but may not be limited to:

• Control-IQ Technology: FDA-approved for individuals 6 years of age and older for the management of type 1 diabetes mellitus (T1DM), requiring insulin. Intended for use with compatible integrated continuous glucose monitors (iCGMs) and ACE pumps to automatically increase, decrease and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 8 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 9 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• MiniMed 770G: FDA-approved for individuals 2 years of age and older for T1DM, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. BLE capable for two-way wireless communication with the combo meter to deliver insulin and adjust pump settings remotely. The MiniMed 770G system consists of the following devices: MiniMed 770G insulin pump, the Guardian Link 3 transmitter, the Guardian Sensor 3, one- press serter, the Accu-Chek Guide Link blood glucose meter and the Accu-Chek Guide test strips.

Older for T1DM, requiring insulin. Intended for use to deliver insulin via a tubeless insulin pump (Pod). Pods are worn directly on the body and changed every three days. The system integrates the tubeless insulin delivery Pods with Dexcom G6 CGM and a smartphone app or a separate controller device to automatically adjust insulin. Within the app is a SmartBolus calculator that receives Dexcom CGM values every five minutes and automatically adjusts insulin up or down or pauses it based on predicted values for 60 minutes into the future and the individual's customized glucose targets.

Automated Insulin Delivery (Artificial Pancreas, Closed Loop) Fully automated, closed-loop glucose management system with a continuous glucose monitor and an insulin pump programmed with a computer algorithm that calculates insulin and glucagon doses from the CGM readings and tells the pump to deliver or temporarily suspend or reduce insulin based upon specified thresholds of measured glucose levels. (Refer to Coverage Limitations section)

For information regarding prescription digital therapeutics/mobile health (mHealth) applications (apps) to support diabetes management, please refer to Digital Therapeutics Medical Coverage Policy.

Coverage Determination

Any state mandates for CGMS or insulin pumps take precedence over this medical coverage policy.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 10 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Humana members may be eligible under the Plan for FDA-approved professional diagnostic/short-term CGMS on a periodic basis when ALL of the following criteria are met:

• Individual has been diagnosed with diabetes mellitus requiring insulin and inadequate glycemic control as noted with frequent self-monitoring and recurring episodes of severe hypoglycemia (less than 70 mg/dl) and fasting hyperglycemia (greater than 150 mg/dl); AND
• Monitoring sessions limited to 3 to 14 days; AND
• No more than two monitoring sessions within a 12-month period

Humana members may be eligible under the Plan for personal/long-term use of CGMS or CGMS with implantable interstitial glucose sensors (eg, Eversense/Eversense E3) as an adjunct to or replacement for fingerstick testing (according to the FDA-approved indications) of blood glucose when the following criteria are met:

• Individual has been diagnosed with diabetes mellitus that requires a treatment program of multiple injections of insulin, with frequent self-adjustment of insulin doses; AND
• Requested device is being prescribed according to its FDA-approved indications; AND either of the following:
• Documented* history of hypoglycemic unawareness; OR
• Documented* history of inadequate glycemic control (despite compliance) of recurrent (at least 2 events within a 30-day period), severe hypoglycemic events (blood glucose less than 70 mg/dL) despite appropriate modifications in insulin therapy and member compliance

Continuous Glucose Monitoring Systems and Insulin Pumps Effective Date: 07/01/2023 Revision Date: 07/01/2023 Review Date: 04/27/2023 Policy Number: HUM-0372-044 Page: 11 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

External Insulin Pumps

Humana members may be eligible under the Plan for the use of an FDA-approved external insulin pump and related drugs/supplies (except batteries ) as medically necessary when the following criteria are met:

• Documentation that demonstrates a program of multiple injections of insulin (eg, at least 3 injections per day), with frequent self-adjustment of insulin doses for at least six months prior to initiation of the insulin pump; AND
• Individual and/or caretaker (for child, adolescent, youth) has completed a comprehensive diabetes education program within the past 12 months if they are a first time user of insulin pump therapy; AND
• Requested device is being prescribed according to its FDA-approved indications; AND
• Individual has a documented glycosylated hemoglobin level (HbA1c) greater than 7.0 AND meets at least one of the following criteria while on multiple daily injections of insulin:
• Documentation* of dawn phenomenon with fasting blood sugars frequently (at least 2 events within a 30 day period) exceeding 200 mg/dl; OR
• Documentation* that demonstrates a pattern of recurrent (at least 2 events within a 30 day period), severe hypoglycemic events (blood glucose less than 70mg/dL) despite appropriate modifications in insulin therapy and member compliance; OR
• Documented* history of severe glycemic excursions; OR
• Documented* history of wide fluctuations in blood glucose before mealtime
• *Documentation must include blood glucose logs for at least a consecutive 20 day period.

It may be considered medically necessary to initiate the use of an external insulin infusion pump during pregnancy earlier than the criteria stated above to avoid fetal

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Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.and maternal complications of diabetes and pregnancy. Only disposable or rental units may be covered for insulin pump therapy that is initiated during pregnancy and is not intended for long-term use.

Note: The criteria for external insulin pumps are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Combination CGMS and External Insulin Pumps

Humana members may be eligible under the Plan for the use of a CGMS (sensor/ transmitter) with wireless communication to a compatible external insulin pump (eg, MiniMed Paradigm REAL-Time Revel System and t:slim X2) or CGMS (sensor/ transmitter) with wireless communication to a compatible external insulin pump and suspend on low feature (eg, MiniMed 530G and 630G System) or hybrid closed loop system (eg, Control-IQ Technology, MiniMed 770G and OmniPod 5) when the following criteria are met:

• Criteria for an external insulin pump has been met as noted above; AND
• Criteria for a long-term CGMS has been met as noted above; AND
• The requested device is being prescribed according to its FDA-approved indications; AND
• Individual does NOT have existing devices that are fully functional and duplicate the same purpose that is served by a CGMS with wireless communication capability to an external insulin pump

Combination CGM/insulin pump devices may be covered by individual component (CGMS vs. insulin pump) when applicable.

Supplies

Humana members may be eligible under the Plan for CGMS and insulin pump supplies and accessories (eg, disposable sensors, infusion sets and pump syringes) required for the proper use of a medically necessary device, in accordance with the manufacturer’s guidelines, to assure proper functioning of the equipment.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 13 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Replacement

Please consult the member’s individual certificate regarding Plan coverage for replacement of DME.

Commercial Plan members: requests for replacement of CGMS and insulin pump equipment due to manufacturing limitations and/or device incompatibility require review by a medical director.

Replacement of purchased DME and diabetes equipment** is a covered expense if:

• Device is being prescribed according to its FDA-approved indications; AND
• Manufacturer’s warranty has expired; AND
• Replacement cost is less than the repair cost; AND
• Replacement is required due to current equipment being nonfunctional (malfunctioning and cannot be repaired); AND
• Replacement is not due to lost or stolen device/equipment, misuse or abuse of the equipment

**Coverage will be based on the individual component(s) of the device that are affected.

Add-ons/upgrades:

Please consult the member’s individual certificate regarding Plan coverage for add-ons or upgrades. When add-ons or upgrades are beyond what is necessary to meet the individual’s basic functional medical needs, they are generally considered not medically necessary.

Duplicate Equipment

Please consult the member’s individual certificate regarding Plan coverage for duplicate or similar equipment, which includes, but may not be limited to, equipment with the same function for use in another location (eg, school, second residence, travel, work) as it may be excluded by certificate.

In the absence of a certificate exclusion, this is considered not medically necessary as defined in the member’s individual certificate.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 14 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for CGMS, external insulin pumps, CGMS (sensor/transmitter) with wireless communication to a compatible external insulin pump or CGMS (sensor/transmitter) with wireless communication to a compatible external insulin pump and suspend on low feature (eg, MiniMed 530G and 630G System) or hybrid closed loop system (eg, Control-IQ Technology, MiniMed 770G and OmniPod 5) for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the plan for the following devices for any indication:

• Automated insulin delivery system (eg, artificial pancreas, closed loop) insulin pumps; OR
• Implantable insulin pumps

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following, for any indication:

• MiniMed Connect; OR
• mySentry remote monitoring system; OR
• Nonintegrated batteries (eg, AA, AAA, lithium, rechargeable) for external insulin pumps

These are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Continuous Glucose Monitoring Systems and Insulin Pumps
Effective Date: 07/01/2023
Revision Date: 07/01/2023
Review Date: 04/27/2023
Policy Number: HUM-0372-044
Page: 15 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Note: The criteria for implantable insulin pumps are consistent with the Medicare National Coverage Policy and therefore apply to Medicare members.

Additional information about T1DM or type 2 diabetes mellitus (T2DM) may be found from the following websites:

Background

• American Association of Clinical Endocrinologists
• American Diabetes Association
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.