CurrentWest Virginia Bureau for Medical Services (Department of Human Services)Policy N/A

Omnipod Insulin Management System prior authorization

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Prior authorization criteria for coverage of the Omnipod insulin management system for West Virginia Bureau for Medical Services members; describes clinical and documentation requirements for initial and continued coverage.

Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyOmnipod Insulin Management System prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2021

Last ReviewDec 13, 2021

Next Review DateN/A

Key ActionSubmit documentation of diabetic education and glucose logs showing self-testing at least 4 times per day for the 3 months prior to the request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval duration

>=4/dayself-testing frequency

>=6 monthsprior regimen compliance

>=3/day

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CurrentWest Virginia Bureau for Medical Services (Department of Human Services)Policy N/A

Omnipod Insulin Management System prior authorization

Customize your policy alerts

Sign up for all West Virginia Bureau for Medical Services (Department of Human Services) policy alerts

Know when West Virginia Bureau for Medical Services (Department of Human Services) releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyOmnipod Insulin Management System prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2021

Last ReviewDec 13, 2021

Next Review DateN/A

Key ActionSubmit documentation of diabetic education and glucose logs showing self-testing at least 4 times per day for the 3 months prior to the request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval duration

>=4/dayself-testing frequency

>=6 monthsprior regimen compliance

>=3/day

Coverage Criteria for Omnipod Insulin Management System

inv-01: Initial authorization — Prior authorization requests for the Omnipod insulin management system may be approved if the following criteria are met.

Prior authorization requests for the Omnipod insulin management system may be approved if the following criteria are met:

Baseline requirements: Patient must be diagnosed with Type I or Type II Diabetes; documentation of diabetic education; meet manufacturer's age restrictions; compliant on current antidiabetic regimen for at least the last 6 months including multiple daily injections (>=3 per day); and provide documentation of glucose self-testing >=4 times/day during the 3 months prior to request.

All conditions required

inv-14: Initial therapy — Initial authorization criteria (detailed nested criteria for starting Omnipod).

Initial authorization criteria

Initial therapy baseline: Diagnosis of Type I or Type II Diabetes; diabetic education documented; meets manufacturer's age restrictions; compliant on current antidiabetic regimen >=6 months with multiple daily injections (>=3/day); glucose self-testing >=4/day for prior 3 months.

All required

Initial therapy additional: One of: documented history of recurring hypoglycemia; OR wide fluctuations in pre-meal blood glucose, history of severe glycemic excursions, or 'Dawn' phenomenon with fasting blood glucose exceeding 200 mg/dL; OR prior use of an insulin pump with documented glucose self-testing >=4/day in the month immediately prior to the request.

At least one required

inv-02: Renewal/Continuation — Criteria for additional therapy approval.

Criteria for additional therapy approval

Renewal requirements: Documentation of satisfactory patient response (including current HbA1C) is required to approve additional therapy beyond the initial 6-month approval.

All listed required

inv-15: Continuation criteria — Continuation requires evidence of benefit.

Continuation requires evidence of benefit

Continuation: Satisfactory patient response documented, including current HbA1C, is required to approve additional therapy after the initial 6-month period.

The Omnipod system is an insulin delivery platform comprised of a disposable, tubeless wearable pod and a separate Personal Diabetes Manager (PDM). The PDM contains the Freestyle blood glucose meter and communicates wirelessly with the pod; it is a separate unit that is not waterproof and must be within 5 feet of the pod to maintain communication. The pods are not cross-compatible between the original Omnipod system and the Omnipod DASH system. The Omnipod is not a continuous glucose monitor (CGM); it provides insulin delivery only.

Clinical Thresholds & Usage Metrics

inv-04: Self-monitoring frequency — required glucose self-testing frequency (at least 4 times per day)

Required frequencyGlucose self-testing at least 4 times per day (documented in glucose log for the 3 months prior to request)

Documentation periodLogs must cover the 3 months prior to the prior authorization request

Associated criterionMeets baseline requirement #5 for initial authorization

inv-05: Prior regimen duration — required prior compliance on current antidiabetic regimen (at least 6 months compliant)

Required durationPatient must have been compliant on current antidiabetic regimen for at least the last 6 months

Regimen requirementCurrent regimen must include multiple daily injections of insulin

Provider Actions, Documentation & Decision Triggers

Prior Authorization

Omnipod prior authorization criteria — meet all baseline criteria and ≥1 additional clinical criterion

Prior authorization requests for the Omnipod Insulin Management System may be approved only when all baseline requirements are met and at least one additional clinical criterion is documented. Baseline requirements that must all be satisfied include diagnosis of Type I or Type II diabetes; documentation of diabetic education; meeting manufacturer's age restrictions; documented compliance on the current antidiabetic regimen for at least the last 6 months including multiple daily injections (≥3 per day); and submission of a glucose log showing self-testing at least 4 times per day during the 3 months prior to the request. At least one of the additional criteria must also be met: documented recurring hypoglycemia; wide pre-meal glucose fluctuations/severe excursions or Dawn phenomenon with fasting glucose >200 mg/dL; or prior insulin pump use with documented glucose testing ≥4/day in the month immediately prior to the request.

All baseline criteria must be met: diagnosis of Type I or Type II diabetes; diabetic education documented; meets manufacturer age restrictions; compliant on current antidiabetic regimen ≥6 months including ≥3 injections/day; glucose self-testing ≥4 times/day during the 3 months prior to request.
At least one additional clinical criterion required: (a) recurring hypoglycemia; (b) wide fluctuations/severe excursions or Dawn phenomenon with fasting glucose >200 mg/dL; or (c) prior insulin pump use with documented glucose testing ≥4/day in the month prior.

Background & Definitions

The Omnipod Insulin Management System is a compact, tubeless, waterproof wearable device that provides up to 72 hours of continuous insulin delivery. Insulin delivery from the pod is controlled by a separate Personal Diabetes Manager (PDM) which includes a Freestyle blood glucose meter. The PDM must remain within 5 feet of the pod to communicate, and the PDM itself is not waterproof. The system’s pods deliver insulin only and do not function as a continuous glucose monitoring device.

inv-13: Omnipod (system components) — Definitions of system components: pod, PDM, meter notes, compatibility and waterproof distinctions

PodA wearable, tubeless, waterproof device that delivers insulin for up to 72 hours; pods are not cross-compatible between original Omnipod and Omnipod DASH

Personal Diabetes Manager (PDM)Separate unit that communicates wirelessly with the pod; includes the Freestyle blood glucose meter; PDM is NOT waterproof and must be within 5 feet of the pod to communicate

Meter noteThe Freestyle meter is built into the PDM; the Omnipod system is NOT a continuous glucose monitor

CompatibilityPods from original Omnipod are not cross-compatible with Omnipod DASH pods

Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyOmnipod Insulin Management System prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2021

Last ReviewDec 13, 2021

Next Review DateN/A

Key ActionSubmit documentation of diabetic education and glucose logs showing self-testing at least 4 times per day for the 3 months prior to the request.

SourceLink

On This Page

Related denial triggerNoncompliance on current antidiabetic regimen for at least 6 months may trigger denial if not documented

inv-06: Minimum prior injections — required prior multiple daily injections (at least 3 injections per day)

Minimum injections per dayRegimen must include multiple daily injections requiring at least 3 injections per day

Documentation contextThis injection frequency is part of the 6-month compliance requirement for the current antidiabetic regimen

Role in criteriaSpecifies prior intensive insulin therapy prior to Omnipod authorization

inv-07: Fasting blood glucose threshold (Dawn phenomenon) — threshold exceeding 200 mg/dL

Fasting glucose threshold'Dawn' phenomenon defined as fasting blood glucose exceeding 200 mg/dL

Clinical contextUsed as one of the 'additional clinical criteria' (at least one required) for initial authorization

Alternative criteria groupingCan be met instead of recurring hypoglycemia or prior pump use with documented testing

Step Therapy

Initial approval 6 months; renewal requires documented response including current HbA1C

Initial approvals are granted for a 6-month period. To obtain approval beyond the initial 6 months, submit documentation demonstrating satisfactory patient response to therapy, including the patient’s current HbA1C.

Initial approval duration: 6 months.
Renewal requirement: documentation of satisfactory patient response including current HbA1C.

Documentation Required

Required documentation to support prior authorization request

Include supporting records with the prior authorization request: documentation that the patient received diabetic education; a glucose log showing self-testing at least 4 times per day for the 3 months prior to the request; evidence of compliance on the current antidiabetic regimen for at least the last 6 months (including documentation of multiple daily injections ≥3/day); and prior pump use records if claiming prior pump therapy.

Diabetic education documentation must be submitted.
Glucose logs must show self-testing ≥4 times/day during the 3 months prior to the request.
Evidence of compliance on current antidiabetic regimen for ≥6 months, including documentation of ≥3 insulin injections per day.
If claiming prior pump use as the additional criterion, provide records documenting insulin pump use and glucose testing ≥4/day in the month immediately prior to the request.

Denial Risk

Triggers that may lead to denial of Omnipod prior authorization

The following deficiencies may trigger denial of the prior authorization request: failure to document diabetic education; lack of evidence of compliance on the current antidiabetic regimen for at least 6 months; history showing fewer than 3 insulin injections per day; or insufficient self-monitoring frequency (fewer than 4 self-tests per day during the 3 months prior).

No documentation of diabetic education.
Noncompliance on current antidiabetic regimen for <6 months or lack of evidence of compliance.
History of fewer than 3 daily insulin injections.
Glucose logs showing self-testing <4 times/day in the 3 months prior to request.

Waterproof distinctionPods are waterproof, but the PDM is not; maintain PDM within 5 feet for communication