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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHealth Choice Arizona Part B Prior Auth | OpenPaye…
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    CurrentHealth Choice ArizonaPolicy JC35.0

    Medicare Part B (Outpatient) Step Therapy Program for Drugs/Products

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    This policy governs prior authorization and step therapy for specified non-preferred medical-benefit injectable drugs and products covered under Medicare Part B. It applies to new therapy for Health Choice Arizona Medicare members and generally requires use of a preferred alternative before approval of a non-preferred product.

    Policy Summary
    PayerHealth Choice Arizona
    PolicyMedicare Part B (Outpatient) Step Therapy Program for Drugs/Products
    Policy CodePolicy JC35.0
    Change TypeNew policy
    Effective DateJanuary 1, 2020
    Last ReviewSep 3, 2019
    Next Review DateNot specified
    Key ActionObtain prior authorization and document qualifying preferred-agent use within 120 days before requesting a listed non-preferred product.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    7Criteria required for step therapy approval
    120 daysPreferred-agent use lookback
    4Non-preferred drug/product groupings

    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.

    4Preferred alternative products
    Medicare Part BBenefit scope

    Coverage Criteria

    Initial therapy for non-preferred products

    Step Therapy will apply when all of the following are met:

    Step therapy approval criteria

    • Medicare Part B status: The requested drug/product meets the definition of a Medicare outpatient (Part B) drug.
    • New therapy: The requested drug/product is for a new therapy for a member not actively receiving the requested drug/product.
    • Medically accepted indication: The proposed use of the requested product has been determined to be a medically accepted indication.
    • Dose, frequency, and duration: The proposed dose, frequency, and duration of use will not exceed the safety and efficacy data supporting the medically accepted indication.
    • Preferred-agent indication: Previous use of the preferred alternative agent was for a medically accepted indication.
    • Recent preferred-agent use: Previous use of the preferred alternative agent occurred within the past 120 days from the date of request for the requested drug/product.within 120 days
    • Clinical response attestation: The prescriber attests that use of the preferred alternative resulted in a minimal clinical response and that the clinical response is expected to be superior with the requested non-preferred drug/product.

      Prescriber attestation required.

    A member cannot be required under this policy to change from a current non-preferred drug or product when the member has a paid claim for that product within the past 120 days. This protection applies to new plan members using the product at enrollment and to existing members when the policy is updated.

    Covered Products and Coding

    Non-Preferred Drugs/ProductsHCPCS
    J0885Epogen/Procrit
    J0178Eylea
    J2778Lucentis
    J2503Macugen
    J2505Neulasta
    J1442Neupogen
    Preferred Alternative Drugs/ProductsHCPCS
    Q5106Retacrit
    J7999Avastin intravitreal
    Q5108Fulphila
    Q5111Udenyca
    Q5101Zarxio
    Q5110Nivestym
    Preferred alternative use lookback
    Lookback periodWithin the past 120 days from the date of request
    Required prior useThe preferred alternative agent must have been used before the requested drug or product
    Indication requirementThe previous use of the preferred alternative must have been for a medically accepted indication

    Provider Requirements and Decision Risks

    Prior Authorization

    Prior Authorization Required for Non-Preferred Products

    Prior authorization is required before prescribing or administering a listed non-preferred medical-benefit injectable drug or product under Medicare Part B.

    • Non-preferred products: Epogen/Procrit (J0885), Eylea (J0178), Lucentis (J2778), Macugen (J2503), Neulasta (J2505), and Neupogen (J1442).
    • Preferred alternatives listed in the policy include Retacrit (Q5106), Avastin intravitreal (J7999), Fulphila (Q5108), Udenyca (Q5111), Zarxio (Q5101), and Nivestym (Q5110).
    Step Therapy

    Preferred Alternative Required

    The requested non-preferred drug/product must be preceded by use of the corresponding preferred alternative in the same medical-benefit injectable class, subject to the policy criteria.

    • A member with a current non-preferred drug/product is not required to switch. A current product is one with a paid claim within the past 120 days.
    • New plan members and existing members affected by a policy update are likewise not required to change a current drug/product.

    Policy Background

    This policy applies to selected Medicare Part B medical-benefit injectable therapies, including erythropoiesis-stimulating agents, intravitreal ophthalmic agents, and colony-stimulating factors. Listed non-preferred products require prior authorization and, for new therapy, qualifying use of the corresponding preferred alternative before approval. Coverage is evaluated with applicable Medicare coverage requirements, medical-necessity criteria, and benefit-plan provisions.

    Key Definitions

    Current drug/product
    DefinitionA current drug or product is one for which the member has a paid claim within the past 120 days
    New plan membersA new plan member using a particular drug or product is not required under this policy to switch to the preferred drug or product upon enrollment
    Existing membersAn existing member using a particular drug or product is not required to change drugs or products when this policy is updated
    New therapy
    DefinitionTherapy for a member who is not actively receiving the requested drug or product
    Requested productThe requested drug or product must be for a new therapy for the member

    Initial Therapy Criteria

    Initial therapy

    Step Therapy will apply when all of the following are met:

    Step therapy approval criteria

    • Medicare Part B status: The requested drug/product meets the definition of a Medicare outpatient (Part B) drug.
    • New therapy: The requested drug/product is for a new therapy for a member not actively receiving the requested drug/product.
    • Medically accepted indication: The proposed use of the requested product has been determined to be a medically accepted indication.
    • Dose, frequency, and duration:

    Preferred Alternative Requirements

    Non-preferred drug/productCorresponding preferred alternative(s)Requirements
    Epogen/Procrit (J0885)Retacrit (Q5106)For new therapy, use for a medically accepted indication within 120 days before the request; prescriber attestation of minimal clinical response and expected superior response is required.
    Eylea (J0178), Lucentis (J2778), or Macugen (J2503)Avastin intravitreal (J7999)For new therapy, use for a medically accepted indication within 120 days before the request; prescriber attestation of minimal clinical response and expected superior response is required.
    Neulasta (J2505)Fulphila (Q5108) or Udenyca (Q5111)For new therapy, use for a medically accepted indication within 120 days before the request; prescriber attestation of minimal clinical response and expected superior response is required.
    Neupogen (J1442)Zarxio (Q5101) or Nivestym (Q5110)For new therapy, use for a medically accepted indication within 120 days before the request; prescriber attestation of minimal clinical response and expected superior response is required.

    Product-Specific Preferred Alternatives

    Step Therapy

    Epogen/Procrit: use Retacrit first

    For new therapy involving Epogen/Procrit (J0885), use Retacrit as the preferred alternative before requesting the non-preferred product.

    • Preferred alternative: Retacrit (Q5106).
    Step Therapy

    Intravitreal products: use Avastin intravitreal first

    For new therapy involving Eylea (J0178), Lucentis (J2778), or Macugen (J2503), use Avastin intravitreal as the preferred alternative.

    • Preferred alternative: Avastin intravitreal (J7999).
    Step Therapy

    Neulasta: use Fulphila or Udenyca first

    For new therapy involving Neulasta (J2505), use Fulphila or Udenyca as the preferred alternative.

    Policy Summary
    PayerHealth Choice Arizona
    PolicyMedicare Part B (Outpatient) Step Therapy Program for Drugs/Products
    Policy CodePolicy JC35.0
    Change TypeNew policy
    Effective DateJanuary 1, 2020
    Last ReviewSep 3, 2019
    Next Review DateNot specified
    Key ActionObtain prior authorization and document qualifying preferred-agent use within 120 days before requesting a listed non-preferred product.
    SourceLink
    On This Page
    Coverage CriteriaCovered Products and CodingProvider Requirements and Decision RisksPolicy BackgroundKey DefinitionsInitial Therapy CriteriaPreferred Alternative RequirementsProduct-Specific Preferred Alternatives

    Unsupported block type: documentation

    Unsupported block type: documentation

    Unsupported block type: documentation

    Denial Risk

    Unauthorized Administration May Result in Claim Denial

    If a provider administers a non-preferred drug/product without obtaining prior authorization, Health Choice may deny the claim for that non-preferred drug/product.

    • Obtain authorization before administration of the non-preferred product.
    • Claim denial risk applies to the non-preferred drug/product administered without prior authorization.
    Step Therapy

    Step Therapy Criteria Not Met

    Approval may be denied when the requested drug/product does not satisfy the policy’s step-therapy criteria. All listed criteria must be met for step therapy to apply and for the request to qualify under this policy.

    • The request must involve a Medicare outpatient (Part B) drug and a new therapy for a member not actively receiving the requested product.
    • The proposed use must be a medically accepted indication, with dose, frequency, and duration within supporting safety and efficacy data.
    • The preferred alternative must have been used for a medically accepted indication within 120 days before the request.
    • The prescriber must attest to minimal clinical response with the preferred alternative and expected superior response with the requested non-preferred product.
    Step therapy applicationStep therapy applies when the requested product is for a new therapy
    Preferred and non-preferred product
    Non-preferred drug or productA listed medical-benefit injectable subject to prior authorization and step therapy
    Preferred alternativeThe corresponding drug or product that must generally be used first for new therapy
    Policy treatmentFor a new therapy, prior use of the preferred alternative is required before approval of the listed non-preferred drug or product, subject to the policy criteria
    The proposed dose, frequency, and duration of use will not exceed the safety and efficacy data supporting the medically accepted indication.
  1. Preferred-agent indication: Previous use of the preferred alternative agent was for a medically accepted indication.
  2. Recent preferred-agent use: Previous use of the preferred alternative agent occurred within the past 120 days from the date of request for the requested drug/product.within 120 days
  3. Clinical response attestation: The prescriber attests that use of the preferred alternative resulted in a minimal clinical response and that the clinical response is expected to be superior with the requested non-preferred drug/product.

    Prescriber attestation required.

  4. Preferred alternatives: Fulphila (Q5108) or Udenyca (Q5111).
    5. Step Therapy

    Neupogen: use Zarxio or Nivestym first

    For new therapy involving Neupogen (J1442), use Zarxio or Nivestym as the preferred alternative.

    • Preferred alternatives: Zarxio (Q5101) or Nivestym (Q5110).