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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyCommunity Health Choice SevenFact Coverage | OpenP…
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    CurrentCommunity Health ChoicePolicy N/A

    SevenFact Criteria for Coverage

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    This policy governs medical-necessity review and prior authorization for SevenFact in Community Health Choice members with hemophilia A or B and high-titer factor inhibitors, including bleeding-episode treatment, control, and perioperative bleeding management.

    Policy Summary
    PayerCommunity Health Choice
    PolicySevenFact Criteria for Coverage
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2024
    Next Review DateN/A
    Key ActionSubmit a prior authorization request with documentation that the initial or continuation coverage criteria are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥12 yearsMinimum member age
    ≥5 BURequired inhibitor level
    2Qualifying diagnoses
    2Covered request purposes
    J7212SevenFact HCPCS code

    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.

    Medical Necessity Criteria

    Initial Therapy

    Covered when ALL of the following are met:

    Initial Coverage Criteria

    • Prescriber requirement: SevenFact is prescribed by or in consultation with a hematologist.
    • Age requirement: Member is greater than or equal to 12 years of age.>=12 years
    • Qualifying diagnosis

      • Hemophilia A with a history of high-titer factor VIII inhibitors.>=5 Bethesda units
      • Hemophilia B with a history of high-titer factor IX inhibitors.>=5 Bethesda units
    • Request purpose

      • Bleeding episode: Treatment and control of a bleeding episode.
      • Perioperative management: Perioperative bleeding management.

    Continuation Therapy

    Covered when ALL of the following are met:

    Continuation Coverage Criteria

    • Initial criteria remain met: Member meets the initial coverage criteria.
    • Beneficial response: Documentation of beneficial response to therapy.

    Billing and Coding Information

    Applicable HCPCS CodeHCPCSCovered
    J7212Factor VIIa (antihemophilic factor, recombinant)-jncw (SevenFact), 1 microgram
    Applicable Diagnosis CodesICD-10
    D66Hereditary factor VIII deficiency
    D67Hereditary factor IX deficiency
    D68.2Hereditary deficiency of other clotting factors
    D68.311Acquired hemophilia
    Member Age
    Minimum ageAt least 12 years
    Applies toMember
    Coverage criterionMember is greater than or equal to 12 years of age
    Factor VIII Inhibitor Titer
    Minimum inhibitor titerAt least 5 Bethesda units
    Associated conditionHemophilia A
    Inhibitor requirementHistory of high-titer factor VIII inhibitors

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for SevenFact. Requests are subject to medical-necessity review against the policy’s initial or continuation coverage criteria before coverage is authorized.

    Documentation Required

    Initial Request Documentation

    Include complete documentation with the initial request to support medical-necessity review and establish that all initial coverage criteria are met.

    • Prescriber information confirming SevenFact is prescribed by or in consultation with a hematologist.
    • Member age: the member is 12 years of age or older.
    • Diagnosis and inhibitor history: hemophilia A with high-titer factor VIII inhibitors (≥5 Bethesda units), or hemophilia B with high-titer factor IX inhibitors (≥5 Bethesda units).
    • Treatment purpose: treatment and control of a bleeding episode, or perioperative bleeding management.

    Policy Background

    SevenFact® (coagulation factor VIIa [recombinant]-jncw) is a recombinant factor VIIa therapy used for members with hemophilia A or B who have high-titer factor inhibitors. This policy addresses medically necessary use in members aged 12 years and older for treatment and control of a bleeding episode or for perioperative bleeding management.

    Policy Summary
    PayerCommunity Health Choice
    PolicySevenFact Criteria for Coverage
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2024
    Next Review DateN/A
    Key ActionSubmit a prior authorization request with documentation that the initial or continuation coverage criteria are met.
    SourceLink
    On This Page
    Medical Necessity CriteriaBilling and Coding InformationAuthorization and Documentation RequirementsPolicy Background
    Factor IX Inhibitor Titer
    Minimum inhibitor titerAt least 5 Bethesda units
    Associated conditionHemophilia B
    Inhibitor requirementHistory of high-titer factor IX inhibitors
    Documentation Required

    Continuation Documentation

    For continuation requests, document that the member continues to meet the initial coverage criteria and that therapy has produced a beneficial response.

    • Ongoing eligibility under the initial criteria, including the qualifying diagnosis, inhibitor history, age requirement, hematologist involvement, and covered treatment purpose.
    • Clinical documentation of beneficial response to SevenFact therapy.
    Denial Risk

    Initial Criteria Not Met

    The initial request should be denied when the member does not satisfy all initial coverage criteria or when the required supporting documentation is absent.

    • No prescription by or consultation with a hematologist.
    • Member is younger than 12 years of age.
    • No qualifying diagnosis of hemophilia A with high-titer factor VIII inhibitors (≥5 Bethesda units) or hemophilia B with high-titer factor IX inhibitors (≥5 Bethesda units).
    • Request is not for treatment and control of a bleeding episode or perioperative bleeding management.
    Denial Risk

    Continuation Criteria Not Met

    A continuation request should be denied when ongoing eligibility under the initial criteria is not established or documentation of beneficial response to therapy is absent.

    • The member no longer meets the initial coverage criteria.
    • The request does not include documentation of a beneficial response to SevenFact therapy.