CGM4U program

PROGRAMS TERMS AND CONDITIONS:

• The Continuous Glucose Monitor (CGM) Pathway Program is for CGM transmitter upgrades only. CGM supplies and consumables are not included, unless otherwise stated.
• Customers must have a Medtronic in-warranty transmitter to participate in the CGM Pathway Program.
• Customers transitioning from one Medtronic CGM system will not have any upfront out-of-pocket costs to Pathway to another Medtronic CGM transmitter.
• Upon completion of the transaction, customers will receive one (1) transmitter that is the latest technology compatible with their current pump system.
• The CGM Pathway Program does not extend the warranty period of the replaced product. The customer’s current warranty timeline will not change by obtaining a CGM transmitter through this program.
• Offer applies to a maximum of one (1) transmitter per customer and cannot be used in conjunction with the MiniMed™ 780G System Program or Competitor CGM Pathway Program.
• Customers who do not purchase supplies from Medtronic should call Medtronic to participate in the program. Ongoing supplies should continue to be purchased through current supply provider (distributor).
• Certain labeling restrictions for MiniMed™ CGM may exclude certain populations, including age and type of diabetes. We recommend you consult your Healthcare Provider regarding indications for use.
• A valid prescription will be required to obtain a new CGM. Other restrictions may apply.
• Customers should verify that their insurance provider will support transitioning to the new CGM, as it could affect ongoing coverage of their future CGM supplies.
• This program is available to customers whose payers bill transmitters and sensors separately. Customers whose payers utilize a monthly CGM supply allowance are excluded from this program.
• Customers will be able to receive up to two (2) boxes of Guardian™ 4 sensors at no cost if Medtronic Guardian™ Sensor 3 were purchased in the last 90 days.
• Special restrictions apply for customers with commercial insurance residing in Massachusetts & Michigan and/or customers enrolled in any federal, state, or government-funded healthcare. Refer to special circumstances’ terms & conditions.
• Kaiser health plans are excluded from this program.
• Program terms and conditions are subject to change at any time and without notice.

• Special circumstances apply for customers with commercial insurance residing in Michigan & Massachusetts; and/or customers with federal, state, and government-funded healthcare.
• Customers must return their old transmitter within 30 days. Customers who do not return their CGM will be charged $200.
• Customers are not able to receive up to two (2) boxes of Guardian™ 4 sensors at no cost if Medtronic Guardian™ Sensor 3 were purchased in the last 90 days.
• Customer agrees that the amount paid to Medtronic is commercially reasonable considering the approximate value of the exchanged CGM, the price of the new CGM, and the relationship between the parties.
• As applicable, Customer agrees to fully and accurately report in submissions to federal healthcare programs all discounts provided by Medtronic and, upon request by the Secretary of the U.S. Department of Health and Human Services or state agency, make available information any information that Medtronic may provide concerning the discount.

• Offer is available until April 27, 2024 to existing Medtronic customers upgrading to or purchasing the MiniMed™ 780G system with commercial insurance.
• The MiniMed™ 780G System Program is for CGM upgrades only. CGM transmitters and sensors are included with this transaction.
• Customers must have an out-of-warranty transmitter (Medtronic or competitor) or no CGM to participate in the MiniMed™ 780G System Program.
• Customers will pay $100 out-of-pocket to purchase one (1) Medtronic Guardian™ 4 CGM transmitter and one (1) 5-pack of Guardian™ 4 sensors. A customer's insurance will not be billed for this initial order.
• Customers will be able to receive up to two (2) boxes of Guardian™ 4 sensors at no cost if Medtronic Guardian™ Sensor 3 were purchased in the last 90 days.
• Customers who do not purchase supplies from Medtronic should call Medtronic to participate in the program. Ongoing supplies should continue to be purchased through current supply provider (distributor).
• Offer applies to a maximum of one (1) Guardian™ 4 transmitter per customer and cannot be used in conjunction with the CGM Pathway Program or Competitor CGM Pathway Program.
• Customers who decide not to continue with the Medtronic Guardian™ 4 CGM have 60-days from date of purchase to initiate the refund process and Medtronic will refund the $100 out of pocket that was paid.
• MiniMed™ CGM have certain labeling restrictions that may exclude certain populations, including age and type of diabetes. We recommend you consult your Healthcare Provider regarding indications for use.
• A valid prescription will be required to obtain a new CGM. Other restrictions may apply.
• Customers should verify that their insurance provider will support transitioning to the new CGM, as it could affect ongoing coverage of their future CGM supplies.
• This program is only available to customers whose payers bill transmitters and sensors separately. Customers whose payers utilize a monthly CGM supply allowance are excluded from this program.
• Customers with commercial insurance residing in Massachusetts & Michigan and/or customers enrolled in any federal, state, or government-funded healthcare are excluded from this program.
• Kaiser & Excellus health plans are excluded from this program.
• Program terms and conditions are subject to change at any time and without notice.

• The Competitor Continuous Glucose Monitor (CGM) Pathway Program is for Competitor CGM upgrades only. CGM transmitters and sensors are included with this transaction.
• Customers must have an in-warranty transmitter to participate in the Competitor Continuous Glucose Monitor (CGM) Pathway Program.
• Customers using disposable CGM systems like Freestyle Libre or Dexcom G7 are not eligible for the Competitor CGM Pathway Program.
• Customers transitioning from a Competitor CGM will pay $100 out-of-pocket to purchase one (1) Medtronic CGM transmitter that is compatible with their current therapy regimen and one (1) 5-pack of sensors.
• The Competitor CGM Pathway Program does not extend the warranty period of the replaced product. The customer’s current warranty timeline will not change by purchasing a CGM through this program.
• Offer applies to a maximum of one (1) transmitter per customer and cannot be used in conjunction with the CGM Pathway Program or MiniMed™ 780G System Program.
• Customers have 60-days from date of purchase to initiate the refund process and Medtronic will refund the $100 out of pocket that was paid.
• This program is available to customers whose payers bill transmitters and sensors separately. Customers whose payers utilize a monthly CGM supply allowance are excluded from this program.
• Certain labeling restrictions for MiniMed™ CGM may exclude certain populations, including age and type of diabetes. We recommend you consult your Healthcare Provider regarding indications for use.
• Customers should verify that their insurance provider will support transitioning to the new CGM, as it could affect ongoing coverage of their future CGM supplies.
• A valid prescription will be required to obtain a new CGM. Other restrictions may apply.
• Special restrictions apply for customers with commercial insurance residing in Massachusetts & Michigan and/or customers enrolled in any federal, state, or government-funded healthcare. Refer to special circumstances terms & conditions.
• Kaiser health plans are excluded from this program.
• Program terms and conditions are subject to change at any time and without notice.

• Special circumstances apply for customers with commercial insurance residing in Michigan & Massachusetts; and/or customers with federal, state, and government-funded healthcare.
• Customers must return their old transmitter within 30 days. Customers who do not return their CGM will be charged $200.
• Customer agrees that the amount paid to Medtronic is commercially reasonable considering the approximate value of the exchanged CGM, the price of the new CGM, and the relationship between the parties.
• As applicable, Customer agrees to fully and accurately report in submissions to federal healthcare programs all discounts provided by Medtronic and, upon request by the Secretary of the U.S. Department of Health and Human Services or state agency, make available information any information that Medtronic may provide concerning the discount.

• The Continuous Glucose Monitor (CGM) Supply Allowance Process is for CGM upgrades only. CGM supplies are included as prescribed.
• Customers transitioning from one CGM system will not have any upfront out-of-pocket transmitter cost for the opportunity to transition to another CGM transmitter.
• Applicable out-of-pocket CGM supply costs will apply.
• Upon completion of the transaction, customers will receive one (1) transmitter that is the latest technology compatible with their current pump system along with their monthly one (1) 5-pack of compatible sensors and other CGM supplies as prescribed.
• This process is available to customers whose payers utilize a monthly CGM supply allowance. Customers with insurance providers that bill transmitters and sensors separately are excluded from this process.
• MiniMed^™ CGM's have certain labeling restrictions that may exclude certain populations, including age and type of diabetes. We recommend you consult your Healthcare Provider regarding indications for use.
• Customers should verify that their insurance provider will support transitioning to the new CGM, as it could affect ongoing coverage of their future CGM supplies.
• A valid prescription will be required to obtain a new CGM. Other restrictions may apply.
• Process terms and conditions are subject to change at any time and without notice.

Important safety information: MiniMed^™ 780G system with SmartGuard^™technology with Guardian^™ 4 sensor
The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 780G system includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 780G system consists of the following devices: MiniMed^™ 780G insulin pump, the Guardian^™ 4 transmitter, the Guardian^™ 4 sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ 4 sensor is indicated for up to seven days of continuous use.

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the SmartGuard^™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard^™ feature.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

Important Safety Information: MiniMed^™ 770G System With SmartGuard^™ Technology
The MiniMed^™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user slectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 770G System includes SmartGuard^™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose values (SG) and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic 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 AccuChek®Guide Test Strips. The system requires a prescription.

The Guardian^™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian^™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

warning: Do not use the SmartGuard^™ Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in SmartGuard^™ Auto Mode.

warning: Do not use the MiniMed^™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 770G system.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed^™ 770G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library

Important Safety Information: Guardian^™ Connect CGM System
The Guardian^™ Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide and important safety information.