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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid Doxepin PA | OpenPayer
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    CurrentNorth Carolina MedicaidPolicy N/A

    Outpatient Pharmacy Prior Approval Criteria: Topical Antihistamines

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    Prior approval coverage criteria for topical doxepin used for short-term management of moderate pruritus in adults with atopic dermatitis or lichen simplex chronicus.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyOutpatient Pharmacy Prior Approval Criteria: Topical Antihistamines
    Policy CodePolicy N/A
    Change TypeAdministrative updateno clinical changes
    Effective DateFebruary 25, 2019
    Last ReviewApr 1, 2023
    Next Review DateNot specified
    Key ActionSubmit prior approval requests that satisfy the applicable initial or continuation criteria.
    SourceLink
    POLICY UPDATE CHANGES

    NC Health Choice language was removed during the October 20, 2023 criteria review.

    3Listed topical doxepin products
    2Covered clinical indications
    10 daysMaximum therapy duration
    45 g/90 daysQuantity limit

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    3 months
    Minimum interval between renewals

    Coverage Criteria

    Initial Therapy

    Covered for short-term management of moderate pruritus in adults when ALL applicable criteria are met:

    ALL of the following

    • ONE of the following indications

      • Atopic Dermatitis

        • Beneficiary has atopic dermatitis with moderate pruritus.
        • Previous treatment with at least one other topical antihistamine.
        • Previous treatment with at least two topical steroid creams.
        • Length of therapy may be approved for up to 10 days.<= 10 days
        • Quantity limit applies.45 grams per 90 days

      • Lichen Simplex Chronicus

        • Beneficiary has lichen simplex chronicus with moderate pruritus.
        • Previous treatment with at least two topical steroid creams.
        • Length of therapy may be approved for up to 10 days.<= 10 days
        • Quantity limit applies.45 grams per 90 days
    • Prior approval is required when required by the applicable Medicaid coverage process; EPSDT does not eliminate the prior-approval requirement.

    Continuation Therapy

    Continuation coverage (renewal) is available when ALL of the following are met:

    ALL of the following

    • Initial coverage criteria above are met.
    • Documentation indicates that the beneficiary benefited from therapy but remains at high risk.
    • At least 3 months have passed between prior uses.>= 3 months
    • Length of therapy may be approved for up to 10 days.<= 10 days
    • Quantity limit applies.

    Beneficiary Eligibility and EPSDT Provisions

    Coverage is subject to the following beneficiary eligibility and EPSDT provisions:

    ALL of the following

    • Beneficiary is enrolled in North Carolina Medicaid on the date of service.
    • Beneficiary's eligibility category does not impose service restrictions that make the requested service ineligible.
    • For beneficiaries under 21 years of age, EPSDT applies when the requested service is medically necessary to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination.
    • Under EPSDT, medically necessary services must be provided in the most economic mode when the alternative is similarly efficacious, the determination does not delay delivery of needed care, and the determination does not limit the beneficiary's free choice of providers.
    • Provider documentation must demonstrate how the requested service meets all applicable EPSDT criteria, including improving or maintaining the beneficiary's health, compensating for a health problem, preventing worsening, or preventing additional health problems.

    EPSDT does not require North Carolina Medicaid to provide a service, product, or procedure that is unsafe, ineffective, or experimental/investigational, or that is not medical in nature or generally recognized as an accepted method of medical practice or treatment. For beneficiaries under 21 years of age, clinical-policy limitations on scope, amount, duration, frequency, location, or other specific criteria may be exceeded or may not apply when provider documentation establishes that the requested service is medically necessary to correct or ameliorate the identified defect, illness, or condition and meets all applicable EPSDT requirements.

    Coding and Utilization Limits

    Therapeutic Class Codemixed
    L3PDermatological Antipruritics-Antihistamines Topical
    Maximum length of therapy
    Atopic dermatitisLength of therapy may be approved for up to 10 days.
    Lichen simplex chronicusLength of therapy may be approved for up to 10 days.
    Renewal requestsLength of therapy may be approved for up to 10 days.
    Quantity limit
    Prudoxin 5% creamQuantity limit of 45 grams per 90 days.
    Zonalon 5% creamQuantity limit of 45 grams per 90 days.
    Doxepin 5% cream

    Provider Requirements and Action Items

    Prior Authorization

    Prior Approval Required

    Prior approval is required when requested topical antihistamine therapy is subject to prior approval. EPSDT does not eliminate the prior approval requirement. Coverage is indicated for the short-term management of moderate pruritus in adults with atopic dermatitis or lichen simplex chronicus.

    Step Therapy

    Atopic Dermatitis Prerequisite Therapy

    For atopic dermatitis, document previous treatment with at least one other topical antihistamine and at least two topical steroid creams. Approved therapy may be limited to up to 10 days and 45 grams per 90 days.

    • Previous treatment with at least one other topical antihistamine
    • Previous treatment with at least two topical steroid creams
    • Maximum duration: up to 10 days
    • Quantity limit: 45 grams per 90 days

    Policy Background

    This policy addresses topical doxepin, a topical antihistamine, for the short-term management of moderate pruritus in adults with atopic dermatitis or lichen simplex chronicus. Coverage is subject to specified prior topical therapies, short treatment durations, and quantity limits.

    Definitions

    EPSDT
    MeaningEarly and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal Medicaid requirement.
    Who is coveredThe requirement applies to Medicaid beneficiaries under 21 years of age.
    Coverage requirementThe state Medicaid agency must cover medically necessary services, products, or procedures needed to correct or ameliorate an identified defect, physical or mental illness, or condition.
    LimitationsEPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment.

    Initial Therapy by Indication

    Continuation of Coverage

    Required Prior Therapies

    ConditionPrior treatment required
    Atopic dermatitisPrevious treatment with at least one other topical antihistamine and at least two topical steroid creams
    ConditionPrior treatment required
    Lichen simplex chronicusPrevious treatment with at least two topical steroid creams

    Product Quantity Limits

    Listed topical doxepin products
    Prudoxin 5% cream45 grams per 90 days.
    Zonalon 5% cream45 grams per 90 days.
    Doxepin 5% cream45 grams per 90 days.
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyOutpatient Pharmacy Prior Approval Criteria: Topical Antihistamines
    Policy CodePolicy N/A
    Change TypeAdministrative updateno clinical changes
    Effective DateFebruary 25, 2019
    Last ReviewApr 1, 2023
    Next Review DateNot specified
    Key ActionSubmit prior approval requests that satisfy the applicable initial or continuation criteria.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Utilization LimitsProvider Requirements and Action ItemsPolicy BackgroundDefinitionsInitial Therapy by IndicationContinuation of CoverageRequired Prior TherapiesProduct Quantity Limits
    45 grams per 90 days
  1. EPSDT does not eliminate prior approval when prior approval is required.
    2. Quantity limit of 45 grams per 90 days.
    Minimum interval between prior uses
    Minimum intervalAt least 3 months must have passed between prior uses.
    Renewal documentationDocumentation must indicate that the beneficiary benefited from therapy but remains at high risk.
    Renewal duration and quantityRenewal therapy may be approved for up to 10 days, with a quantity limit of 45 grams per 90 days.
    Step Therapy

    Lichen Simplex Chronicus Prerequisite Therapy

    For lichen simplex chronicus, document previous treatment with at least two topical steroid creams. Approved therapy may be limited to up to 10 days and 45 grams per 90 days.

    • Previous treatment with at least two topical steroid creams
    • Maximum duration: up to 10 days
    • Quantity limit: 45 grams per 90 days
    Documentation Required

    Renewal Documentation: Benefit and Continued Risk

    For a renewal request, document that the initial criteria were met, the beneficiary benefited from therapy, and the beneficiary remains at high risk. At least three months must have passed between prior uses.

    • Initial criteria must be met
    • Document benefit from therapy and continued high risk
    • Minimum interval between prior uses: 3 months
    • Maximum duration: up to 10 days
    • Quantity limit: 45 grams per 90 days
    Documentation Required

    EPSDT Medical-Necessity Documentation

    For beneficiaries under 21, an EPSDT exception requires provider documentation showing that the requested service is medically necessary to correct or ameliorate an identified condition and meets EPSDT criteria. EPSDT limits may be exceeded or may not apply only when the documentation supports the exception; EPSDT does not remove a prior approval requirement.

    • Document how the therapy will correct, improve, or maintain the beneficiary’s health; compensate for a health problem; prevent worsening; or prevent additional health problems
    • The service must be medically necessary, similarly efficacious when a more economic option is used, and delivered without delaying needed care
    • EPSDT does not require coverage of services that are unsafe, ineffective, experimental/investigational, or not medical in nature or generally recognized as accepted treatment
    Denial Risk

    Failure to Meet Clinical or Utilization Criteria

    The request may be denied when the clinical indication, prerequisite therapy, renewal documentation, or utilization limits are not satisfied. Prior approval remains required, including for EPSDT requests.

    • Requested use is not short-term management of moderate pruritus in an adult with atopic dermatitis or lichen simplex chronicus
    • Required prior topical antihistamine or topical steroid therapy is not documented
    • For renewal, benefit from therapy, continued high risk, or the required 3-month interval is not documented or satisfied
    • Requested duration exceeds 10 days or quantity exceeds 45 grams per 90 days