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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health BiCNU Prior Auth Coverage | OpenPaye…
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    CurrentClover HealthPolicy 4808-A

    BiCNU (carmustine) Coverage Criteria

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    Prior authorization for BiCNU (carmustine) under Clover Health Medicare Part B for specified FDA-approved and compendial oncology indications when approval criteria are met and applicable exclusions do not apply.

    Policy Summary
    PayerClover Health
    PolicyBiCNU (carmustine) Coverage Criteria
    Policy CodePolicy 4808-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit supporting evidence from Medicare-approved compendia for indications not enumerated in the policy.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsAuthorization period
    4FDA-approved indication categories
    8Compendial use categories
    3Continuation criteria domains

    Covered Indications and Exclusions

    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.

    Central nervous system cancers

    Authorization of 12 months may be granted when the member is being treated for a covered central nervous system cancer.

    Covered central nervous system cancer

    • Glioblastoma
    • Adult glioma
    • Anaplastic gliomas
    • Pediatric diffuse high-grade glioma
    • Medulloblastoma
    • Astrocytoma
    • Ependymoma
    • Primary CNS lymphoma
    • Metastatic brain tumors

    Multiple myeloma

    Authorization of 12 months may be granted when the following condition is met.

    Multiple myeloma regimen: BiCNU is used to treat multiple myeloma in combination with prednisone.

    Lymphoma and other covered malignancies

    Authorization of 12 months may be granted for treatment of the applicable covered malignancy.

    Covered non-CNS malignancy

    • Lymphoma: Relapsed, refractory, or heavily pretreated lymphoma
    • Mycosis fungoides or Sezary syndrome
    • Adult T-cell leukemia/lymphoma: Chronic or smoldering adult T-cell leukemia/lymphoma
    • Waldenstrom macroglobulinemia
    • Gastric carcinoma

    Continuation therapy

    Authorization of 12 months may be granted when all of the following criteria are met.

    • Current BiCNU therapy: The member is currently receiving therapy with BiCNU.
    • Covered indication: BiCNU is being used to treat an indication enumerated in Section II.

    • Clinical benefit

      • Tolerability: There is no evidence of unacceptable toxicity while the member is on the current regimen.
      • Disease control: There is no evidence of disease progression while the member is on the current regimen.

    Coverage is available only when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

    Indications other than those enumerated in the policy are assessed individually. Requests for an unlisted indication must include supporting evidence from Medicare-approved compendia.

    Authorization and Submission Guidance

    Prior Authorization

    Central Nervous System Cancers

    Prior authorization may be granted for 12 months for treatment of covered central nervous system cancers when the applicable approval criteria are met and no exclusions apply.

    • Covered CNS cancers include glioblastoma, adult glioma, anaplastic gliomas, pediatric diffuse high-grade glioma, medulloblastoma, astrocytoma, ependymoma, primary CNS lymphoma, and metastatic brain tumors.
    Prior Authorization

    Multiple Myeloma With Prednisone

    Prior authorization may be granted for 12 months for multiple myeloma when BiCNU (carmustine) is used in combination with prednisone.

    • Submit documentation confirming the multiple myeloma diagnosis and concurrent prednisone use.
    Prior Authorization

    Relapsed or Refractory Lymphoma

    Prior authorization may be granted for 12 months for treatment of relapsed, refractory, or heavily pretreated lymphoma.

    • Submit documentation supporting the lymphoma diagnosis and relapsed, refractory, or heavily pretreated status.
    Prior Authorization

    Mycosis Fungoides or Sezary Syndrome

    Prior authorization may be granted for 12 months for treatment of mycosis fungoides or Sezary syndrome.

    • Submit documentation confirming the applicable diagnosis.
    Prior Authorization

    Adult T-Cell Leukemia/Lymphoma

    Prior authorization may be granted for 12 months for treatment of chronic or smoldering adult T-cell leukemia/lymphoma.

    • Submit documentation confirming the diagnosis and chronic or smoldering disease status.
    Prior Authorization

    Waldenstrom Macroglobulinemia

    Prior authorization may be granted for 12 months for treatment of Waldenstrom macroglobulinemia.

    • Submit documentation confirming the diagnosis.
    Prior Authorization

    Gastric Carcinoma

    Prior authorization may be granted for 12 months for treatment of gastric carcinoma.

    • Submit documentation confirming the diagnosis.
    Prior Authorization

    Advanced Melanoma

    Prior authorization may be granted for 12 months for treatment of advanced melanoma.

    • Submit documentation confirming advanced disease.

    Unsupported block type: documentation

    Unsupported block type: denial_risk

    Unsupported block type: documentation

    Unsupported block type: denial_risk

    Therapy Overview

    BiCNU (carmustine) is used as palliative chemotherapy, either as a single agent or in combination with other approved chemotherapeutic agents. The policy addresses FDA-approved oncology indications and selected compendial uses across central nervous system cancers, hematologic malignancies, gastric carcinoma, and advanced melanoma.

    Clinical Benefit Definition

    Benefit from therapy
    Current therapyThe member must be currently receiving therapy with BiCNU.
    Covered indicationBiCNU must be used to treat an indication enumerated in Section II.
    Clinical benefitBenefit from therapy requires no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.
    Authorization periodContinuation authorization may be granted for 12 months when all criteria are met.

    Initial Therapy

    Initial therapy

    Authorization of 12 months may be granted for the following covered indication-specific uses.

    Covered initial indication

    • Central nervous system cancer, including glioblastoma, adult glioma, anaplastic gliomas, pediatric diffuse high-grade glioma, medulloblastoma, astrocytoma, ependymoma, primary CNS lymphoma, or metastatic brain tumors
    • Multiple myeloma treated with BiCNU in combination with prednisone
    • Lymphoma: Relapsed, refractory, or heavily pretreated lymphoma
    • Mycosis fungoides or Sezary syndrome
    • Adult T-cell leukemia/lymphoma: Chronic or smoldering adult T-cell leukemia/lymphoma
    • Waldenstrom macroglobulinemia
    • Gastric carcinoma
    • Advanced melanoma

    Continuation Therapy

    Continuation therapy

    Authorization of 12 months may be granted when all of the following criteria are met.

    Continuation of BiCNU

    • Current BiCNU therapy: The member is currently receiving therapy with BiCNU.
    • Covered indication: BiCNU is being used to treat an indication enumerated in Section II.

    • Clinical benefit

      • Tolerability: There is no evidence of unacceptable toxicity while the member is on the current regimen.
      • Disease control: There is no evidence of disease progression while the member is on the current regimen.
    Policy Summary
    PayerClover Health
    PolicyBiCNU (carmustine) Coverage Criteria
    Policy CodePolicy 4808-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit supporting evidence from Medicare-approved compendia for indications not enumerated in the policy.
    SourceLink
    On This Page
    Covered Indications and ExclusionsAuthorization and Submission GuidanceTherapy OverviewClinical Benefit DefinitionInitial TherapyContinuation Therapy
    Advanced melanoma