InPen Smart Insulin Pen
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Recommended prior authorization criteria for coverage of the InPen smart insulin pen system (reusable Bluetooth-enabled pen plus app) for members using compatible U-100 rapid-acting insulins. Applies to payer coverage determinations for Medical Mutual - Ohio.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Initial coverage criteria — Diabetes Mellitus
Covered when ALL of the following are met
Coverage is not recommended for circumstances that are not specifically listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.
Use of InPen for indications or circumstances not listed in the Recommended Authorization Criteria is not recommended for approval.
Prior Authorization & Documentation Requirements
Prior authorization recommended
Prior authorization is recommended for pharmacy benefit coverage of InPen; approval is recommended when the member meets the conditions of coverage in the policy's Criteria and Initial/Extended Approval sections.
No step therapy required
There are no step therapy requirements or specified prior-failure trials required by this policy for InPen.
Company may request supporting documentation
The Company may request additional documentation to support medical necessity; failure to provide requested records may affect coverage determinations.
- Documentation that may be requested includes patient records, test results, and provider credentials.
- Additional information must be made available upon request to support the services provided.
Risk of denial for lack of medical necessity or documentation
The Company may deny reimbursement when the drug or services are not medically necessary, are investigational or experimental, are not within the member's benefits, or when documentation is not provided upon request.
- Denial may follow a determination that services were not medically necessary or were investigational/experimental.
- Denial may follow when requested supporting documentation (e.g., records, test results, provider credentials) is not provided.
Device Background
InPen is an FDA-cleared smart insulin pen system that combines a reusable Bluetooth-enabled insulin pen with a mobile application that records injections and recommends dosing based on current blood glucose, recent insulin dosing, and active insulin. The system is compatible with specified U-100 rapid-acting insulin cartridges, allows dosing from 0.5 to 30 units in 0.5-unit increments, and requires a compatible mobile device (e.g., smartphone or tablet) for app functionality. Use requires the patient to be able and willing to perform blood glucose testing, engage in diabetes self-care, and attend regular follow-up with a healthcare provider.
Key Definitions
Initial Approval Criteria
Initial Approval
Initial approval duration
All initial approvals provided for the duration noted; reauthorization requires response to therapy unless noted otherwise.
Continuation / Extended Approval
Extended Approval
Duration for continuation/extended approval
Reauthorization requires documentation of response to therapy unless otherwise noted.
Intended Setting
Home use requiring compatible smartphone/tablet
InPen is intended for home or self-administration and requires the patient to have access to a compatible smartphone or tablet to use the InPen app.
- App requires a compatible mobile device (e.g., smartphone/tablet) capable of installing and running the InPen app
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