Handling Customer Care

MESSAGING (QUESTIONS AND ANSWERS)
The messaging below should be used only on a reactive basis with customers.
General Questions
Q1. What is the goal of the Medtronic and Aetna collaboration?
The overarching goal of the collaboration is to improve the outcomes for Aetna members with
Type 2 diabetes, through pump therapy, and to help healthcare providers more easily identify and support those who can benefit most from this therapy. By providing selected members with access to insulin pump therapy, the companies hope to achieve better quality of care, improved quality of life and resulting medical cost savings.
Q2. How will the pilot program work?
Using claims data, Aetna will identify more than 300 fully insured members with uncontrolled type 2 diabetes who may be good candidates for insulin pump therapy. Aetna and Medtronic will work with their doctors to alert them to the pilot program and its benefits for the patient. If a doctor and member decide to use a Medtronic insulin pump, the member also will receive targeted education, case management and other patient support from Medtronic to help control their blood sugar. In addition to personalized training on using the insulin pump, members in the pilot will be enrolled in Medtronic’s six-month StartRightSM program that provides additional
“onboarding” support, and Getting2GoalSM, a program helps healthcare providers to successfully transition insulin requiring type 2 patients to insulin pump therapy. The program makes pump therapy simple to start, efficient for healthcare providers, and easy for patients.
Q3. Who is funding the collaboration?
The pilot is designed to follow current business procedures and Aetna’s current medical policy.
Consequently no additional or out-of-the ordinary funding is needed for this collaboration.
Q4. When will this pilot start?
The details of the pilot’s operation are still being finalized.
Q5. What does “value-based arrangements” mean?
Aetna and Medtronic will examine the impact on both overall health outcomes and medical costs for the program.
Q6. Will Medtronic be collaborating with other insurance companies?
Medtronic is currently working exclusively with Aetna to develop a program that responds to the dynamic needs of patients, payers, and healthcare providers. However, we continue to work closely with other payers to develop new opportunities and strategies that share similar objectives and utilize similar concepts.
Q7. Will Aetna be collaborating with other pump companies?
This pilot is currently an exclusive Medtronic-Aetna project.
Q8. How is uncontrolled Type 2 diabetes defined?
Tight glucose control is defined by the American Diabetes Association (ADA) as managing blood glucose as closely to a person without diabetes as possible in a safe manner, keeping A1C <
7%
(http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/tight-diab

etes-control.html). People with diabetes enrolled in the pilot will have to be eligible according to
Aetna policy, have an A1C > 8%, and expresses desire for improved glucose control.
.
Q9. What happens at the end of the pilot? (Can patient keep the pump)?
Patients can keep the pump and will get their pump supplies covered through their insurance companies’ medical benefit and coverage policies.
Q10. What happens to patients that switch insurance companies during the pilot?
The patient will no longer be part of the pilot, but can keep the pump. Pump supplies will be reimbursed pursuant to the patient’s new insurance company’s medical benefit and coverage policy. Q11. Why did Medtronic select Aetna for this program?
Aetna and Medtronic share a common desire to deliver overall value to the US healthcare system and the collaboration has been based on this vision.
Q12. How are the healthcare provider/clinics selected for this program?
Healthcare providers will be identified by Aetna based on eligible patients with Type 2 diabetes in their clinics. An eligible patient is defined as:
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Insulin requiring patients with Type 2 diabetes
•
A1C > 8% within the last 3 months
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Patient expresses desire for improved control
•
Current insulin utilization >0.7 units/kg/day
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Commercial Beneficiary
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Patient meets Aetna’s current CPB for CSII
Q13. The press release states that claims data was used to select patients for this program. How do they do that?
Using claims data, Aetna will identify up to 300 fully-insured members with uncontrolled Type 2 diabetes who may be good candidates for insulin pump therapy and work with healthcare providers to reach them.
Q14. Do patients pay co-pay for the pump, pump supplies? Are there financing options for high out of pocket costs?
The program is designed to follow current business procedures and Aetna’s current medical policy. All co-pays will be according to the patient’s benefits and coverage of the Aetna plan they are enrolled in. Medtronic does offer financial assistance. To check and see if you are eligible for financial assistance, call us Monday through Friday, 8:00 AM - 7:00 PM central time at
1.800.646.4633 and select option 4.
Q15. How is patient eligibility determined for pump therapy? Do all plans cover pump therapy? Patients enrolled in the pilot will have to be eligible according to Aetna policy, have an A1C >
8%, and expresses desire for improved control.
Aetna’s current medical policy defines a patient with Type 2 diabetes as eligible for pump therapy if they meet the following four criteria:

1 The member has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump; and

2 The member has completed a comprehensive diabetes education program; and
3 The member has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump**; and

4 The member meets at least one of the following criteria while on multiple daily injections (more than 3 injections per day) of insulin:

a Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or b Elevated glycosylated hemoglobin level (HbA1c greater than 7.0%, where upper range of normal is less than 6.0%; for other HbA1c assays, 1% over upper range of normal); or c History of recurring hypoglycemia (less than 60 mg/dL); or d History of severe glycemic excursions; or e Wide fluctuations in blood glucose before mealtime (e.g., pre-prandial blood glucose levels commonly exceed 140 mg/dL)
(Source: http://www.aetna.com/cpb/medical/data/100_199/0161.html)
For more detail on Aetna policy please contact Aetna directly.
No other insurance companies participate in this program but Aetna. To get more information on whether your plan reimburses pump therapy, please call 1-888-350-3199.
We will be happy to help you explore your options.
Q16. How are the healthcare providers notified if their patients are selected through the claims data?
Medtronic will contact the healthcare provider to confirm their interest in participating in the pilot.
When confirmed, Aetna will mail the healthcare provider the list of eligible patients from his/her clinic. Q17. The press release mentions targeted education, case management, and patient support, can you clarify what type of education and support patients have access to during this pilot?
People with diabetes participating in the program have access to the all of Medtronic’s e-learnings, Webinars. & live classes as well as personalized training on using the insulin pump.
In addition, members in the pilot will be enrolled in Medtronic’s six-month StartRightSM program that provides additional onboarding support, and Getting2GoalSM, a program helps healthcare providers to successfully transition to insulin pump therapy people with type 2 diabetes who require insulin. The program makes insulin pump therapy simple to start, efficient for healthcare providers, and easy for their patients.
Q18. What clinical endpoints are being collected to define success of this pilot?
This is not a clinical study and no clinical endpoints have been defined as such.
Q19. How will Medtronic know which patients are eligible for a pump? Will Aetna share patient data with Medtronic?
Both Aetna and Medtronic are very committed to complying with HIPAA regulations, and therefore, Aetna member names will not be shared with Medtronic during the selection stage.
Aetna will send a list of eligible member names to the respective healthcare provider/clinics, and they, in collaboration with the member, will determine who if any should consider pump therapy. General pump therapy/Medtronic questions

Q 20. What is pump therapy?
Insulin pump therapy (formally called Continuous subcutaneous insulin infusion) is an advanced method of insulin therapy for people with diabetes. An insulin pump is a small device (about the size of a cell phone) worn externally that delivers insulin around the clock, much like a healthy pancreas. In addition, people with diabetes can start or stop insulin delivery upon demand to normalize glucose levels.
Q21. Why pump therapy for patients with Type 2 diabetes?
Some people with type 2 diabetes become resistant to insulin in earlier stages of the disease or through the progressive nature of the disease requiring additional exogenous insulin. In order to counteract this resistance, the pancreas begins to overproduce insulin, which can eventually result in the damage of β-cells and greatly reduce insulin production. As a result, some people with Type 2 diabetes require insulin as their primary source of therapy.
There are many clinical and lifestyle benefits of insulin pump therapy for people with type 2 diabetes who require insulin. There is a growing body of clinical evidence that shows:

•
•
•

Improved glycemic control in type 2 patients with significant reductions in A1C[1], [2], [3]
Long-term efficacy with improvements in glycemic control maintained for up to 6 years3
Insulin pump therapy results in improved glycemic control and reduction in TDD without compromising weight in type 2 patients.[4], [5]

Studies have reported that near-normal glucose control, which can be achieved with an insulin pump, can also prolong life an average of five years and delay the onset of complications from diabetes, such as blindness, kidney failure, amputation, impotence, coma and heart disease, by an average of 15 years.[6]
Moreover, studies showed that insulin pump therapy offers improved quality of life[7] and that
Type 2 patients preferred pump therapy over MDI.2,[8]
Q22.

Is there clinical evidence to support pump therapy for patients with Type 2 diabetes? (PR states “proven therapy”)?
There is a growing body of global clinical evidence to support pump therapy with patients with
Type 2 diabetes:
[1][1] Edelman SV, et al. Diabetes Technology & Therapeutics. 2010;12(8):627-633.
[2][2] Reznik Y. Diabetes Technology & Therapeutics. 2010;12(12):931-936.
[3][3] Wainstein J, et al. Diabetic Med. 2005:1037-1046.
[4][4] Nielson S, et al. Diabetes Educ. 2005; 31: 843-848.
[5][5] Gentry CK, et al. South Med. 2011; 104 (1): 24-28.
[6][6] Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA, November 6, 1996; 276: No.17.

[7][7] Labrousse-Lhermine F, et al. Diabetes & Metabolism. 2007;22:253-260.
[8][8] Raskin P, et al. Diabetes Care. 2003;26:2598-2603.

a Improved glycemic control in patients with Type 2 diabetes with significant reductions in A1C1-3 b Long-term efficacy with improvements in glycemic control maintained for up to 6 years2 c Pump therapy results in improved glycemic control and reduction in total daily dose (TDD) without compromising weight in Type 2 individuals 4,7 d Offers improved QOL5 e Patient preferred pump therapy over MDI1,6
Q23. What is Getting2GoalSM?
Getting2GoalSM is a program developed by Medtronic to help healthcare providers to successfully transition insulin requiring people with Type 2 diabetes to pump therapy. The program makes pump therapy simple to start, efficient for healthcare providers, and easy for their patients.
Only if needed:
Getting2GoalSM is an onboarding option and Medtronic does not require healthcare provider and patients to adhere to the methodology.
Q24. What is StartRightSM?
StartRightSM is a comprehensive and personalized onboarding program designed to improve outcomes for people with diabetes. With StartRight, customers beginning on insulin pump therapy or continuous glucose monitoring (CGM) receive proactive support and encouragement, along with product education and help building good habits for success, throughout the first six months of their new diabetes management plan.
Q25. Is StartRightSM a requirement for participant in the pilot?
StartRightSM will be offered to all customers, but is not a requirement to be in the pilot.
Q26. Is the patient required to use the MiniMed Revel during the pilot? Or can the patient choose to use another pump?
For the Aetna Medtronic pilot, only MiniMed Revel insulin umps are included. A customer can choose another pump, but will then be excluded from the pilot.
Q27. Is CGM included in the pilot as well?
No, the pilot’s coverage and focus is only on the insulin pump.
Q28. Is the patient required to purchase the pump and supplies during the pilot?
Aetna’s clinical policy covers insulin pumps and pump supplies for members that meet medical criteria. Some co-pay amount based on the member’s benefit plan coverage may occur, and will be specific to the individual.
Healthcare Provider Questions
Q29. How can my practice become a part of the pilot?
Thank you for your interest. If any of your patients living with type 2 diabetes are identified as candidates for the pilot, Medtronic and Aetna will reach out to your practice directly.
Q30. Will I be compensated for my participation this pilot?
No, there is no additional physician or health care provider compensation because the pilot program requires the same activities already being performed today.

Q31. If I participate in the pilot, what will I need to do differently (or extra)?
The pilot will not create any additional activities or burdens for healthcare providers/clinics with respect to insulin pump therapy.
Q32. Who will be training my patients on pump therapy?
Clinics should follow current procedure for pump initiations, including working with Medtronic to facilitate product training for patients.
Q33. I think my patient would benefit from CGM, can that be included in the pilot?
No, the pilot’s focus is only on the pump. In addition, CGM is not covered by Aetna for members with Type 2 diabetes, but if your patient wants to purchase CGM and pay out-of-pocket that is an option.
Q34. Which pump will my patient receive?
Your patients enrolled in the pilot will receive the MiniMed Revel insulin pump.
Q35. Can I see a list of other healthcare providers in my area that participate in the program? No, Aetna and Medtronic will not be sharing pilot specific data with the public.
Q36. Can I see the overall outcome of the pilot when completed?
No, Aetna and Medtronic will not be sharing pilot specific data with the public.
Patient questions
Q37. I would like to use CGM, is it reimbursed through the pilot?
No, the pilot’s focus is only on the insulin pump. CGM is not covered by Aetna for people with
Type 2 diabetes, but if you would like to purchase CGM and pay out-of-pocket that is an option.
We do have payment plans available.
Q38. Aetna is not my insurance company can I still be part of the pilot?
The pilot between Aetna and Medtronic requires you to be an Aetna member to be enrolled. If you are interested in pump therapy please call 1-888-350-3199 and we will be happy to help you explore your options.
Q39. I am a patient with Type 1 diabetes, why is it a Type 2 diabetes only pilot? Are there plans to expand this type of program for patients with Type 1 diabetes?
This pilot program was specifically designed for people living with type 2 diabetes. Medtronic also offers insulin pump therapy and continuous glucose monitoring for people with type 1 diabetes. These customers also receive comprehensive training and onboarding, including enrollment in the StartRight program. If you are interested please call 1-888-350-3199, and we will be happy to help you explore your options.
Q40. If I’m identified as a potential patient will I have to get a pump?
No, it’s up to you and your healthcare provider to determine whether pump therapy is the right choice for you. If you don’t want to get a pump at this point in time, you don’t have to, but you are welcome to have the discussion with your doctor at a later time, or call the Medtronic team at 1-888-350-3199.
Q41.

If I’m identified as a potential patient will I have to get a Medtronic pump?

No, doctors are not required to prescribe Medtronic pumps. However, only members who use
Medtronic pumps will be included in pilot program and have access to Medtronic’s education and support programs.
Q42. Will I be compensated for my participation this pilot?
No, given this in not a clinical study, patients will not be compensated for any part of the pilot.
Q43. I understand the agreement is a “value-based arrangements”, what does that mean to me?
The goal of the agreement is to help Aetna members improve control of their Type 2 diabetes through pump therapy.
Q44. How can I enroll in this program?
At this point the pilot only covers people with type 2 diabetes who are being identified as candidates by Aetna and Medtronic. However if you are interested in pump therapy please call
1-888-350-3199 and we will be happy to help you explore your options.

IMPORTANT SAFETY INFORMATION
- Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems.
- Successful operation of the insulin infusion pumps and/or continuous glucose monitoring systems requires adequate vision and hearing to recognize alerts and alarms.
Medtronic Diabetes Insulin Infusion Pumps
- Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day.
- Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.
Medtronic Diabetes Continuous Glucose Monitoring (CGM) Systems
- The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to treatment.
- Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. For more information, please visit www.medtronicdiabetes.com/importantsafetyinformation.