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    v1.0.31
    OpenPayerPolicy UpdatesEndocrinologyAdvanced Health Omnipod Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentAdvanced HealthPolicy N/A

    Omnipod Drug Use Criteria

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    This policy governs coverage decisions for Omnipod use in members with type 1 or type 2 diabetes and specifies diagnostic, clinical, provider, education, device-necessity, and compatible CGM requirements.

    Policy Summary
    PayerAdvanced Health
    PolicyOmnipod Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument whether the member has a compatible CGM and, if not, request one and document the rationale.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsMaximum approval period
    Type 1Covered diagnostic pathway
    Type 2Additional criteria required
    Dexcom 6CGM for automated delivery
    4Type 2 qualifying circumstances

    Covered Use Criteria

    Type 1 Diabetes

    Covered when the member has type 1 diabetes and the compatible CGM pathway is addressed.

    Type 1 diabetes pathway

    • Member has a diagnosis of type 1 diabetes.
    • Compatible CGM pathway

      • Member has a compatible continuous glucose monitor (CGM).

        Approve for up to 12 months.

      • A compatible CGM is not present; the provider is contacted to request addition of a CGM, and the rationale for not ordering or using one is documented.

        Omnipod automated insulin delivery must be paired with the Dexcom 6 CGM. Approval may be granted for up to 12 months without a CGM.

    Policy Summary
    PayerAdvanced Health
    PolicyOmnipod Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument whether the member has a compatible CGM and, if not, request one and document the rationale.
    SourceLink
    On This Page
    Covered Use CriteriaQualifying Clinical ThresholdsAuthorization and Documentation GuidancePolicy ContextDevice and CGM Terminology

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Type 2 Diabetes

    Covered when ALL provider, education, medical-necessity, and qualifying clinical criteria are met.

    Type 2 diabetes core requirements

    • Member has a diagnosis of type 2 diabetes.
    • The request is from an endocrinologist, or documentation shows that endocrinology is unavailable or not needed.
    • Documentation shows that the member has been educated on how to use the Omnipod device.
    • Documentation establishes that Omnipod is necessary over other insulin pumps available through the durable medical benefit.
    • At least one qualifying clinical circumstance

      • Member is using at least 3 daily insulin injections and has an A1c of at least 7%.At least 3 daily insulin injections; A1c at least 7%
      • Member has a history of hypoglycemia with dawn phenomenon, hypoglycemia unawareness, or nocturnal hypoglycemia.
      • Member is currently pregnant.
      • Member has loss of manual dexterity.
    • Compatible CGM pathway

      • Member has a compatible continuous glucose monitor (CGM).

        Approve for up to 12 months.

      • A compatible CGM is not present; the provider is contacted to request addition of a CGM, and the rationale for not ordering or using one is documented.

        Omnipod automated insulin delivery must be paired with the Dexcom 6 CGM. Approval may be granted for up to 12 months without a CGM.

    Off-label medication use is not a covered benefit. Requests for Omnipod must involve a qualifying diagnosis of type 1 or type 2 diabetes and meet the applicable coverage pathway.

    For members with type 2 diabetes, documentation must establish that Omnipod is necessary over other insulin pumps available through the durable medical benefit. Requests without this Omnipod-specific medical-necessity documentation are not covered.

    Qualifying Clinical Thresholds

    Daily insulin injections
    Minimum daily insulin injectionsAt least 3 daily insulin injections
    A1c
    Qualifying A1cAt least 7%

    Authorization and Documentation Guidance

    Prior Authorization

    Approval Period

    When applicable criteria are met, prior authorization may be approved for up to 12 months. This applies when the member has a compatible CGM or when the required rationale is documented for approval without a CGM.

    • Approval may be granted for up to 12 months for qualifying type 1 or type 2 diabetes requests.
    Documentation Required

    Coordinate Compatible CGM Use

    If a compatible CGM is absent, reach out to the provider to request that one be added and document why a CGM is not ordered or being used. Automated insulin delivery with Omnipod requires pairing with the Dexcom 6 CGM; approval may still be granted for up to 12 months without a CGM when the rationale is documented.

    • Document the provider outreach and the rationale for not ordering or using a compatible CGM.
    • Omnipod automated insulin delivery must be paired with the Dexcom 6 CGM.
    Documentation Required

    Document a Qualifying Diabetes Diagnosis

    Document that the member has a qualifying diabetes diagnosis before requesting Omnipod coverage.

    • Type 1 diabetes qualifies for review under the type 1 pathway.
    • Type 2 diabetes qualifies for review under the type 2 criteria pathway.
    Documentation Required

    Document Provider Specialty Requirements

    For a type 2 diabetes request, document that the request is from an endocrinologist or that endocrinology is unavailable or not needed.

    • Include documentation of endocrinology involvement, availability, or why endocrinology is not needed.
    Documentation Required

    Document Omnipod Education

    For type 2 diabetes, document that the member was educated on how to use the Omnipod device.

    • Include evidence of device-use education in the clinical record.
    Documentation Required

    Document Omnipod-Specific Medical Necessity

    For type 2 diabetes, explain why Omnipod is medically necessary over other insulin pumps available through the durable medical benefit.

    • The documentation must specifically address why other available durable-medical-benefit insulin pumps are not appropriate.
    Documentation Required

    Document CGM Status and Rationale

    Document the member’s compatible CGM status and, when a CGM is not ordered or used, the clinical rationale for that decision.

    • State whether the member has a compatible CGM.
    • If no CGM is ordered or used, document the reason and the provider outreach requesting addition of a CGM.
    Denial Risk

    No Qualifying Diabetes Diagnosis

    Deny the request when the member does not have a diagnosis of type 1 or type 2 diabetes. Off-label use of the medication is not a covered benefit.

    • No qualifying diabetes diagnosis: criteria not met.
    • Off-label use is not covered.
    Denial Risk

    Type 2 Criteria Not Met

    For a member with type 2 diabetes, deny the request when the required provider specialty documentation, device-use education, Omnipod-specific medical-necessity documentation, or qualifying clinical circumstance is not satisfied. Specify which criterion is not met.

    • Required provider: endocrinologist, or documentation that endocrinology is unavailable or not needed.
    • Documentation that the member was educated on Omnipod use.
    • Documentation that Omnipod is necessary over other insulin pumps available through the durable medical benefit.
    • At least one qualifying clinical circumstance must be documented: at least 3 daily insulin injections with A1c at least 7%; history of hypoglycemia with dawn phenomenon, hypoglycemia unawareness, or nocturnal hypoglycemia; current pregnancy; or loss of manual dexterity.
    Denial Risk

    No Qualifying Type 2 Clinical Circumstance

    Deny the request when none of the listed qualifying type 2 clinical circumstances is present.

    • At least 3 daily insulin injections with A1c at least 7%.
    • History of hypoglycemia with dawn phenomenon, hypoglycemia unawareness, or nocturnal hypoglycemia.
    • Currently pregnant.
    • Loss of manual dexterity.

    Policy Context

    Omnipod is an insulin delivery system used in diabetes management. Coverage follows separate pathways for type 1 and type 2 diabetes. Members with type 1 diabetes may be covered when the compatible continuous glucose monitor (CGM) pathway is addressed. Members with type 2 diabetes must also meet requirements for provider specialty or documented endocrinology availability, device-use education, Omnipod-specific medical necessity, and at least one qualifying clinical circumstance. Automated insulin delivery requires pairing Omnipod with the Dexcom 6 CGM.

    Device and CGM Terminology

    Compatible CGM
    DefinitionA continuous glucose monitor compatible with the Omnipod system.
    Automated insulin delivery pairingAutomated insulin delivery requires pairing with the Dexcom 6 CGM.
    Automated insulin delivery
    DefinitionThe Omnipod function that uses CGM information.
    Required pairingTo use automated insulin delivery, Omnipod must be paired with the Dexcom 6 CGM.