CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1386-4

Prior authorization and coverage criteria for Omnipod 5 and Twiist external insulin pumps

Prior authorization and coverage criteria for Omnipod 5 and Twiist external insulin pumps for members; governs initial and reauthorization requirements and who is eligible.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior authorization and coverage criteria for Omnipod 5 and Twiist external insulin pumps

Policy CodePolicy 2025 P 1386-4

Change TypeAdded Twiistannual reference updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis and patient/caregiver motivation and knowledge of nutrition including carbohydrate counting to obtain a 12‑month authorization.

SourceLink

POLICY UPDATE CHANGES

Added Twiist to criteria.

Annual review and updated references in 2023 and 2024.

12 monthsauthorization duration

2+min age Omnipod 5

18+min age Omnipod 5 (T2)

6+min age Twiist

Coverage Criteria

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inv-01: Initial Therapy — Approved when ALL of the following are met:

Approved when ALL of the following are met:

Initial Authorization for Omnipod 5 or Twiist: (A) One of the following: (1) For Omnipod 5: Diagnosis of diabetes; (2) For Twiist: Diagnosis of Type 1 diabetes. AND (B) Both of the following: (1) Patient or caregiver is motivated to assume responsibility for self-care and insulin management; (2) Patient or caregiver demonstrates knowledge of importance of nutrition including carbohydrate counting and meal planning.

Authorization issued for 12 months.

inv-02: Continuation/Reauthorization — Approved for continuation when ALL of the following are met:

Approved for continuation when ALL of the following are met:

Reauthorization for Omnipod 5 or Twiist: Documentation of positive clinical response.

Authorization issued for 12 months.

Coverage is not provided for indications considered unproven per the medical benefit drug policy. This exclusion applies even if other criteria are met and may result in denial of requests for uses outside the documented, evidence-based indications for external insulin pumps.

Initial Therapy

inv-10: Initial therapy — Initial authorization requirements

Initial authorization requirements

Initial: Diagnosis requirement (Omnipod 5: diagnosis of diabetes; Twiist: diagnosis of Type 1 diabetes) AND patient or caregiver motivation to assume responsibility for self-care and insulin management, and demonstration of knowledge of nutrition including carbohydrate counting and meal planning.

Authorization issued for 12 months.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Omnipod 5 and Twiist. Initial authorization requires diagnosis details (diabetes for Omnipod 5; Type 1 diabetes for Twiist) and evidence that the patient or caregiver is motivated and knowledgeable to manage the device and insulin therapy. Authorizations (initial and reauthorization) will be issued for 12 months.

Affected products: Omnipod 5, Twiist
Initial documentation must include: diagnosis (see product-specific diagnosis), evidence patient/caregiver is motivated to assume responsibility for self-care and insulin management, and evidence of knowledge of nutrition including carbohydrate counting and meal planning.
Reauthorization requirement: documentation of positive clinical response
Duration: Authorizations (initial and reauthorization) issued for 12 months

Documentation Required

Required Documentation and Duration

Required documentation must support the diagnosis (diabetes for Omnipod 5; Type 1 diabetes for Twiist), demonstrate that the patient or caregiver is motivated to assume responsibility for self-care and insulin management, and show knowledge of nutrition including carbohydrate counting and meal planning. For reauthorization, documentation must show a positive clinical response. Authorizations (initial and reauthorization) are issued for 12 months.

Initial documentation: product-specific diagnosis, patient/caregiver motivation, nutrition/ carbohydrate counting knowledge
Reauthorization documentation: evidence of positive clinical response

Denial Risk

Denial Risk and Other Rules

Denial Risk / Other Coverage Considerations: Coverage may be limited or denied if indications are unproven per the medical benefit drug policy, supply limits are exceeded, or required documentation is not provided. UnitedHealthcare may, at its discretion, approve initial or reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic via automated processes; use of automated approval varies by program.

Coverage not provided for indications deemed unproven per medical benefit drug policy
Supply limits may apply
Automated approval may occur based on prior claims, medication history, or ICD-10 codes — documentation may still be required

Definitions

External insulin pumps — definition and device description

DefinitionExternal insulin pumps are devices used for managing diabetes that deliver insulin by continuous subcutaneous infusion.

Examples in policyOmniPod 5 and Twiist are named external insulin pump systems covered under this policy.

Indications (age-specific)OmniPod 5: indicated for type 1 diabetes in persons aged 2 and older and for type 2 diabetes in persons aged 18 and older; Twiist: indicated for type 1 diabetes in persons aged 6 and older.

Primary clinical purposeProvide continuous subcutaneous insulin infusion to manage blood glucose in individuals with diabetes.

Coverage contextMembers must meet the policy’s coverage criteria to qualify for device authorization.

Background

External insulin pumps deliver insulin by continuous subcutaneous infusion to manage diabetes. Examples include wearable, external infusion pump systems used to provide continuous basal insulin with on-demand bolus dosing. These devices are intended to support insulin delivery for individuals with diabetes and have age- and indication-specific approvals (see device-specific criteria).

Note: automated prior authorization processes may approve or reauthorize based on prior claims, medication history, and diagnosis codes; supply limits may also apply.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior authorization and coverage criteria for Omnipod 5 and Twiist external insulin pumps

Policy CodePolicy 2025 P 1386-4

Change TypeAdded Twiistannual reference updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis and patient/caregiver motivation and knowledge of nutrition including carbohydrate counting to obtain a 12‑month authorization.

SourceLink

On This Page

OpenPayer

Prior authorization and coverage criteria for Omnipod 5 and Twiist external insulin pumps

Coverage Criteria

Initial Therapy

Continuation / Reauthorization

Provider Actions and Requirements

Definitions

Background