Insulet Omnipod®5

Tubeless, automated insulin delivery

Helps keep you in range during the day and at night
No multiple daily injections, tubes, or fingersticks
Cleared for people with type 1 diabetes ages 2 years and older

*Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.

Specifications

Pod Features

Tubeless, wearable, waterproof
Up to 72 hours of continuous insulin delivery
Automatic
System control from a compatible smartphone

Software Features

Automatically adjusts insulin delivery
Customized target glucose settings
SmartBolus Calculator
Activity feature used during exercise

Increased time in range – Reduced time below range

Lower A1C

Adapted to you- adapt with every Pod change to meet your unique insulin needs and adjusts insulin using a customized Target Glucose, not a range.

The Pod and Dexcom G6 CGM are in constant communication, enabling automatic insulin adjustments to help protect against highs and lows. And, you can control it all from your fingertips with the Omnipod 5 App on a compatible smartphone.

With SmartAdjust™ technology, Omnipod 5 uses your CGM value and trend to automatically increase, decrease, or pause insulin delivery every 5 minutes.

Description

A separate prescription is required for the Dexcom G6 CGM. The Dexcom G6 is sold separately and must be used with the Dexcom G6 mobile app. The Dexcom G6 receiver is not compatible.

* Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.

For a list of compatible smartphone devices, visit omnipod.com/compatibility

In addition to administering and canceling boluses, Omnipod 5 users have full system functionality from a smartphone including initial system configuration, new Pod set up, insulin delivery settings adjustments, alerts & alarms acknowledgement, and more.

SmartAdjust™ technology uses a customizable Target Glucose between 110-150 mg/dL, adjustable in 10 mg/dL increments. Control-IQ™ uses a non-adjustable Target Glucose range of 112.5-160 mg/dL, with an option to use Sleep Activity with a range of 112.5-120 mg/dL. SmartGuard™ Auto Mode uses a non-adjustable target sensor glucose setting of 120 mg/dL.

Risk Statement

The Omnipod 5 Automated Insulin Delivery System is indicated for use by individuals with type 1 diabetes mellitus in persons 2 years of age and older. The Omnipod 5 System is intended for single patient, home use, and requires a prescription. The Omnipod 5 System is compatible with the following U-100 insulins: NovoRapid®, Humalog®, and Admelog®.The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The Omnipod 5 SmartBolus Calculator is intended to calculate a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value.

WARNING: SmartAdjust™ technology should NOT be used by anyone under the age of 2 years old. SmartAdjust™ technology should also NOT be used in people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population. The Omnipod 5 System is NOT recommended for people who are unable to monitor glucose as recommended by their healthcare provider, are unable to maintain contact with their healthcare provider, are unable to use the Omnipod 5 System according to instructions, are taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia, and do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders. Device components including the Pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components. DO NOT start to use the Omnipod 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia. Visit www.omnipod.com/safety for additional important safety information.

Getting Started with the Omnipod® 5 System

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Frequently Asked Questions

Who is responsible for getting the insurance authorizations for medical supplies?

CCS Medical has a team of experienced authorization specialists who will oversee the process. Our knowledgeable staff will contact the ordering physician when applicable and the insurance company to verify coverage and obtain authorization for the product.

Does the company provide service and supplies to Medicare and Medicaid patients?

Yes. We are a participating provider with Medicare as well as most Medicaid and many Managed Care plans.

Are you a participating provider with other insurance companies?

Yes. Our company is contracted with hundreds of insurance providers nationwide. Our knowledgeable customer service team works on a daily basis with hundreds of private health insurers. We add insurance company contracts on an ongoing basis and will be happy to contact any carrier necessary to assist you in meeting your supply needs.

Are all products covered by my insurance company?

Coverage varies from one insurance company to the next. As part of our service, we determine if a particular product will be covered.

How much will a patient have to pay for his or her product?

It depends on the insurance plan and the patient's policy. All patients will be responsible for any co-pays or deductibles that their insurance company may have in place. Our specialists will help explain the patient’s financial responsibilities.

Do I need to apply for Medicare when I turn 65?

No. If you are already getting social security or railroad retirement benefit payments, you will automatically receive a Medicare card in the mail about three months before your 65th birthday as part of an enrollment information package. The card will usually show that you are entitled to both Part A (hospital insurance) and Part B (supplementary medical services). It also indicates the beginning dates of your entitlement to each. If you do not want Part B, follow the instructions that come in the package.

Who can receive benefits for diabetes self-management training?

Individuals covered by Medicare who are at risk for diabetes-related complications and meet other requirements can receive training if it is requested by their doctor or other qualified provider.

How do I know my diabetes supplies are covered by Medicare?

CCS Medical will verify your eligibility and benefits prior to sending your first shipment to ensure your supplies will be covered by Medicare. Deductibles and co-pays may apply.

How much is reimbursed for each product?

After you have paid your annual Medicare Part B deductible, Medicare will reimburse 80% of allowed amount or 80% of the billed amount, whichever is lower.

Does everyone pay the same amount for the Part B premium?

The premium is usually paid by the individual, either through deductions from social security checks or direct billing. The state you reside in may pay Medicare premiums if your income is low enough. Most people pay the same premium amount.

Are there limits on the quantity of diabetes supplies that Medicare will reimburse?

Medicare establishes certain limits based on whether or not you use insulin injections to treat your diabetes. Your physician will indicate how often you should test. Medicare may cover additional testing supplies if your physician determines it is medically necessary.

How do I replace my Medicare card?

Log into (or create) your Medicare account at Medicare.gov to print an official copy of your Medicare card. You can also call 1-800-MEDICARE (1-800-633-4227) to order a replacement card. TTY users can call 1-877-486-2048.

If I am 65 and ready to retire and my employer is going to provide me with benefits, do I need Medicare?

Yes. Medicare pays first in all situations unless you (or your spouse) are eligible under an employer-sponsored group health plan. If you have other questions, visit medicare.gov to learn more.

Does Medicare cover my spouse and family?

In general, Medicare is “individual” insurance. However, sometimes spouses and children can become eligible for Medicare based on the wage earner's work record. For questions about Medicare eligibility, contact the Social Security Administration at 1-800-772-1213.

What is the difference between Medicare and Medicaid?

Medicare is the federal health insurance program. It primarily covers people over age 65, regardless of their income. It also serves younger disabled people and dialysis patients. Patients pay part of the costs through deductibles for hospital and other costs. Small monthly premiums are required for non-hospital coverage. Medicare is a federal program. It is run by the Centers for Medicare and Medicaid Services (CMS), an agency of the federal government, and is basically the same everywhere in the United States.

Medicaid is an assistance program. It serves low-income people of various ages. Medical bills are paid from federal, state and local tax funds. Patients usually pay no part of the costs or very little for covered medical expenses, although a small co-payment is sometimes required. Medicaid is a federal-state program. It is run by state and local governments within federal guidelines, so it varies from state to state.

Medicaid es un programa de asistencia. Atiende a personas de bajos ingresos de distintas edades. Las facturas médicas se pagan con fondos procedentes de los impuestos federales, estatales y locales. Los pacientes suelen pagar poco o nada por los gastos médicos cubiertos, aunque a veces se exige un pequeño copago. Medicaid es un programa federal-estatal. Lo gestionan los gobiernos estatales y locales dentro de las directrices federales, por lo que varía de un estado a otro.

Where should I send my Medicare premium payment?

Please visit https://www.medicare.gov/your-medicare-costs/how-to-pay-part-a-part-b-premiums to see your options for paying your Medicare premium bill.

Who can I contact for more information about Medicare eligibility?

Please visit https://www.medicare.gov/talk-to-someone or call 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.