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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Fibryga Prior Auth Coverage | OpenPa…
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    CurrentClover HealthPolicy 6324-A

    Fibryga (fibrinogen [human]) Coverage and Prior Authorization

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    This policy governs Medicare Part B coverage and authorization for Fibryga, including brand and generic fibrinogen [human] products in all dosage forms and strengths unless otherwise stated. Coverage applies to specified congenital or acquired fibrinogen deficiencies when approval criteria are met and no exclusion applies.

    Policy Summary
    PayerClover Health
    PolicyFibryga (fibrinogen [human]) Coverage and Prior Authorization
    Policy CodePolicy 6324-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests for a 1-month treatment course when the member has a covered fibrinogen deficiency and a qualifying bleeding episode.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 monthStandard authorization duration
    2Covered clinical use categories
    1Explicit use limitation
    2Fibrinogen deficiency categories with criteria

    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

    Congenital Fibrinogen Deficiency

    Authorization may be granted when all of the following are met.

    Required criteria

    • Diagnosis: The member has congenital fibrinogen deficiency, including afibrinogenemia or hypofibrinogenemia.
    • Clinical event: Treatment is for an acute bleeding episode.

    Acquired Fibrinogen Deficiency

    Authorization may be granted when all of the following are met.

    Required criteria

    • Diagnosis: The member has acquired fibrinogen deficiency.
    • Clinical event: Treatment is for a bleeding episode.

    Fibryga is not indicated for dysfibrinogenemia. Coverage for this use is not supported under the policy criteria.

    Authorization and Provider Actions

    Prior Authorization

    Congenital Fibrinogen Deficiency

    Prior authorization for 1 month may be granted for treatment of acute bleeding episodes in members with a diagnosis of congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

    Prior Authorization

    Acquired Fibrinogen Deficiency

    Prior authorization for 1 month may be granted for treatment of bleeding episodes in members with a diagnosis of acquired fibrinogen deficiency.

    Prior Authorization

    Continuation Authorization

    All members, including new members, requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

    Documentation Required

    Compendia Support for Other Indications

    Indications other than those listed in the coverage criteria are assessed on an individual basis. Submissions must be accompanied by supporting evidence from Medicare-approved compendia.

    Denial Risk

    Dysfibrinogenemia

    Fibryga is not indicated for dysfibrinogenemia; coverage is not supported for this use.

    Documentation Required

    Unlisted Indication Without Compendia Support

    Unlisted indications without supporting evidence from Medicare-approved compendia require individual assessment and submission of the supporting compendia evidence.

    Clinical Background

    Fibryga is a human fibrinogen replacement product used to supplement fibrinogen in patients with bleeding associated with acquired fibrinogen deficiency and to treat acute bleeding episodes associated with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

    Fibrinogen Deficiency Definitions

    Afibrinogenemia
    ConditionAfibrinogenemia
    Disorder typeCongenital fibrinogen deficiency disorder
    Fibrinogen statusAbsent fibrinogen
    Hypofibrinogenemia
    ConditionHypofibrinogenemia
    Disorder typeCongenital fibrinogen deficiency disorder
    Fibrinogen statusReduced fibrinogen
    Dysfibrinogenemia
    ConditionDysfibrinogenemia
    Disorder typeFibrinogen disorder
    Policy statusFibryga is not indicated for dysfibrinogenemia

    Initial Therapy Criteria

    Initial Therapy - Congenital Fibrinogen Deficiency

    Authorization of 1 month may be granted when all of the following are met.

    Required criteria

    • Diagnosis: The member has congenital fibrinogen deficiency, including afibrinogenemia or hypofibrinogenemia.
    • Acute bleeding: The member requires treatment for an acute bleeding episode.

    Initial Therapy - Acquired Fibrinogen Deficiency

    Authorization of 1 month may be granted when all of the following are met.

    Required criteria

    • Diagnosis: The member has acquired fibrinogen deficiency.
    • Bleeding episode: The member requires treatment for a bleeding episode.

    Continuation of Therapy

    Continuation of Therapy

    All members, including new members, requesting continuation of therapy must meet all requirements in the coverage criteria.

    Continuation requirements: The member meets all applicable requirements in the coverage criteria for the requested indication.

    Applies to all members, including new members.

    Policy Summary
    PayerClover Health
    PolicyFibryga (fibrinogen [human]) Coverage and Prior Authorization
    Policy CodePolicy 6324-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests for a 1-month treatment course when the member has a covered fibrinogen deficiency and a qualifying bleeding episode.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Provider ActionsClinical BackgroundFibrinogen Deficiency DefinitionsInitial Therapy CriteriaContinuation of Therapy