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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsallcareadvantage Butrans Prior Auth Coverage | Ope…
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    CurrentallcareadvantagePolicy 037.2

    Approval Criteria for Non-Formulary Buprenorphine (Butrans)

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    Defines prior authorization and approval criteria for coverage of transdermal buprenorphine patches (Butrans) for AllCare Advantage members with chronic pain who cannot take oral opioids or use fentanyl patches. Applies to requests for non-formulary Butrans; oral buprenorphine for MAT is handled separately.

    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Non-Formulary Buprenorphine (Butrans)
    Policy CodePolicy 037.2
    Change TypeNo material change
    Effective DateOct 22, 2020
    Last ReviewOct 22, 2022
    Next Review DateOct 22, 2022
    Key ActionObtain prior authorization documenting chronic pain diagnosis, opioid exposure status, inability to take oral medications, and trial/failure or contraindication to alternative therapies.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    4/28dquantity limit for Butrans
    1 yearapproval length
    037.2criteria number
    FDA-approved chronic painindication referenced
    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Non-Formulary Buprenorphine (Butrans)
    Policy CodePolicy 037.2
    Change TypeNo material change
    Effective DateOct 22, 2020
    Last ReviewOct 22, 2022
    Next Review DateOct 22, 2022
    Key ActionObtain prior authorization documenting chronic pain diagnosis, opioid exposure status, inability to take oral medications, and trial/failure or contraindication to alternative therapies.
    SourceLink
    On This Page
    Coverage CriteriaInitial TherapyContinuation TherapyStep Therapy RequirementsProvider Actions and RequirementsQuantity LimitsDefinitionsBackground

    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.

    Coverage Criteria

    Initial approval criteria

    Covered when ALL of the following are met:

    Main criteria: 1) Diagnosis is NOT for opioid dependence (requests for opioid dependence are denied).

    If the diagnosis is for opioid dependence the request must be denied per policy.

    Main criteria: 2) Diagnosis is a chronic pain condition for which opioids would be covered (per FDA-approved indication).

    If not a covered chronic pain condition, deny.

    Main criteria: 3) Member is NOT opioid naïve (opioid‑naïve members are denied).

    Document prior opioid exposure.

    Main criteria: 4) Member is unable to take oral medications (member must be unable to take oral alternatives).

    If member can take oral medications, deny.

    Main criteria: 5) Member has tried and failed, or has a documented contraindication to, alternative therapies (step therapy requirement).

    If no trial/failure or contraindication is documented, deny.

    Requests for buprenorphine when prescribed for medication‑assisted treatment (MAT) of opioid dependence are excluded from this policy and will be reviewed under separate criteria.

    Use of buprenorphine transdermal patches for opioid dependence (MAT), for members who are opioid‑naïve, or for members who are able to take oral medications is considered not meeting approval criteria and will be denied.

    Initial Therapy

    Initial therapy

    Initial coverage requirements

    Initial therapy: Member has a chronic pain condition for which opioids would be covered; member is not opioid naïve; member is unable to take oral medications; member has tried and failed or has a contraindication to alternative therapies; request is not for opioid dependence (MAT).

    If all conditions are satisfied, approve with quantity limit of 4 patches per 28 days.

    Continuation Therapy

    Continuation therapy

    Continuation/approval length and refill limits

    Continuation: Approvals may be granted for up to 1 year subject to quantity limits and demonstration of ongoing clinical need.Up to 1 year

    Quantity limit: 4 patches per 28 days.

    Step Therapy Requirements

    StepRequired prior therapyResulting action
    1Trial of alternative therapies with documented failure or documented contraindication to the alternativesIf tried and failed (or contraindication documented): approve with quantity limit of 4 patches per 28 days; if not: deny

    Provider Actions and Requirements

    Prior Authorization

    Prior authorization required for non‑formulary Butrans

    Prior authorization is required for requests for non‑formulary transdermal buprenorphine (Butrans). Approvals may be granted for up to 1 year and are subject to a quantity limit of 4 patches per 28 days.

    • Approval length: up to 1 year
    • Quantity limit: 4 patches per 28 days
    Step Therapy

    Step therapy: trial and failure required

    Approval requires a prior trial and failure of, or a documented contraindication to, alternative therapies before transdermal buprenorphine will be approved.

    • Must have tried and failed (or have contraindication to) specified alternatives prior to approval

    Quantity Limits

    Quantity limit (per policy)
    Quantity limit4 patches per 28 days
    Unitpatches
    Limit intervalper 28 days
    Policy referenceCriteria number 037.2
    Approval length relatedApprovals may be granted for up to 1 year subject to quantity limits

    Definitions

    Opioid naïve — definition used in policy
    DefinitionOpioid naïve: a patient without prior opioid exposure
    Relevance to coverageRequests for members who are opioid naïve are denied under this policy
    Policy locationReferenced in approval flow criteria #3
    Implication for documentationProvider must document opioid exposure status to demonstrate member is not opioid naïve
    Medication-assisted treatment (MAT) — definition / separation in policy
    DefinitionMedication‑assisted treatment (MAT): use of buprenorphine oral agents for treatment of opioid dependence
    Policy handling

    Background

    Buprenorphine transdermal patches (Butrans) are FDA‑approved for the management of pain severe enough to require daily, around‑the‑clock, long‑term opioid treatment when alternative treatment options are inadequate. This policy distinguishes the transdermal formulation for chronic severe pain from oral buprenorphine products used for medication‑assisted treatment (MAT) of opioid dependence, and limits coverage to members with chronic pain who cannot take oral opioids or use fentanyl patches.

    Documentation Required

    Required documentation to support prior authorization

    Document the member’s diagnosis showing use is for chronic pain (not for opioid dependence/MAT), evidence of prior trials and failures or documented contraindications to alternatives, opioid exposure status (not opioid naïve), and inability to take oral medications.

    • Diagnosis must be a chronic pain condition for which opioids would be covered
    • Document prior trials and failures or contraindications to alternatives
    • Document that member is not opioid naïve
    • Document inability to take oral medications
    Denial Risk

    Denial triggers and risks

    Requests will be denied if the indication is for opioid dependence (medication‑assisted treatment), if the diagnosis is not a chronic pain condition for which opioids would be covered, if the member is opioid naïve, if the member can take oral medications, or if required alternative therapies have not been tried and failed (and no contraindication is documented).

    • Diagnosis for opioid dependence (MAT) → deny
    • Diagnosis not a covered chronic pain condition → deny
    • Member opioid naïve → deny
    • Member able to take oral medications → deny
    • No trial of (or contraindication to) required alternatives → deny
    Requests for buprenorphine oral agents for MAT are reviewed under separate criteria and are excluded from this transdermal patch policy
    Denial triggerIf the diagnosis is for opioid dependence (MAT), request is denied under this policy
    Scope noteThis policy applies to transdermal buprenorphine patches for chronic pain, not oral buprenorphine for MAT