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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid Vowst Prior Auth | OpenPay…
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    CurrentNorth Carolina MedicaidPolicy N/A

    Vowst Medicaid Outpatient Pharmacy Prior Approval Criteria

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    This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Vowst, a fecal microbiota transplantation product, in eligible Medicaid beneficiaries. Coverage is subject to age, recurrent Clostridioides difficile infection, pretreatment, bowel preparation, safety, and duration criteria.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyVowst Medicaid Outpatient Pharmacy Prior Approval Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionSubmit prior approval documentation confirming eligibility, recurrent C. difficile infection with at least three episodes within 12 months, required pretreatment and bowel preparation, and absence of safety exclusions.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥18 yearsMinimum beneficiary age for standard coverage
    ≥3 in 12 monthsRequired recurrent CDI episodes
    2–4 daysInterval from antibiotics to Vowst
    30 days

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    Maximum therapy duration

    Coverage Criteria

    Initial Vowst Therapy

    Covered when ALL of the following are met:

    Required coverage criteria

    • Age: Beneficiary is at least 18 years of age≥18 years
    • Diagnosis: Beneficiary has a confirmed diagnosis of recurrent Clostridioides difficile infection (CDI) with a total of at least 3 episodes of CDI within 12 months≥3 CDI episodes within 12 months
    • Pretreatment: Antibiotic treatment for recurrent CDI must be completed 2 to 4 days prior to initiation of Vowst therapy2–4 days before Vowst initiation
    • Bowel preparation: Beneficiary will take 10 oz of magnesium citrate, or 250 mL polyethylene glycol electrolyte solution for patients with impaired kidney function, the evening prior to initiation of Vowst therapyEvening before Vowst initiation
    • Safety: Beneficiary must not have absolute neutrophil count (ANC) below 500 cells/mm3, toxic megacolon, or small bowel ileusANC must not be <500 cells/mm3

    Coverage excludes beneficiaries with an absolute neutrophil count (ANC) below 500 cells/mm3, toxic megacolon, or small bowel ileus.

    Clinical Thresholds

    Recurrent CDI episode count
    Required diagnosisConfirmed recurrent Clostridioides difficile infection (CDI)
    Minimum episode count≥3 CDI episodes
    Measurement periodWithin 12 months
    Absolute neutrophil count
    Safety measureAbsolute neutrophil count (ANC)
    Minimum thresholdANC must not be <500 cells/mm3
    Related safety exclusionsToxic megacolon or small bowel ileus

    Provider Requirements and Decision Points

    Prior Authorization

    Initial Coverage Requirements

    Prior approval is required for Vowst coverage. The beneficiary must be at least 18 years old and meet the clinical requirements for recurrent Clostridioides difficile infection and treatment preparation.

    • Beneficiary is ≥ 18 years of age.
    • Confirmed recurrent CDI with ≥ 3 total episodes within 12 months.
    • Complete antibiotic treatment for recurrent CDI 2–4 days before starting Vowst.
    • Take 10 oz of magnesium citrate, or 250 mL polyethylene glycol electrolyte solution the evening before initiation when kidney function is impaired.
    Denial Risk

    Required Safety Criteria

    Before approval, confirm that the beneficiary meets the required safety criteria. Vowst must not be used when any of the listed safety exclusions is present.

    Clinical Background

    Vowst is a fecal microbiota transplantation product covered under this policy for the treatment of confirmed recurrent Clostridioides difficile infection (CDI). Coverage applies when the beneficiary has experienced at least 3 CDI episodes within 12 months and recurrent CDI antibiotic treatment has been completed 2 to 4 days before Vowst initiation.

    Definitions

    EPSDT
    MeaningEarly and Periodic Screening, Diagnostic, and Treatment (EPSDT)
    Who is coveredMedicaid beneficiaries under 21 years of age
    Federal requirementCoverage is required for medically necessary services, products, or procedures needed to correct or ameliorate a qualifying defect, physical or mental illness, or condition
    Prior approvalBeing under 21 years of age does not eliminate a prior approval requirement when the service, product, or procedure requires prior approval

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial Vowst therapy is covered when ALL of the following criteria are met:

    Initial Vowst therapy criteria

    • Age: Beneficiary is at least 18 years of age≥18 years
    • Confirmed recurrent CDI: Beneficiary has a confirmed diagnosis of recurrent Clostridioides difficile infection (CDI) with a total of at least 3 episodes of CDI within 12 months≥3 CDI episodes within 12 months
    • Antibiotic treatment for recurrent CDI must be completed 2 to 4 days prior to initiation of Vowst therapy2–4 days before Vowst initiation

    Quantity Limits

    Quantity limits
    ProductVowst
    Maximum approved durationUp to 30 days
    Limit typeLength of therapy per course
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyVowst Medicaid Outpatient Pharmacy Prior Approval Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionSubmit prior approval documentation confirming eligibility, recurrent C. difficile infection with at least three episodes within 12 months, required pretreatment and bowel preparation, and absence of safety exclusions.
    SourceLink
    On This Page
    Coverage CriteriaClinical ThresholdsProvider Requirements and Decision PointsClinical BackgroundDefinitionsInitial Therapy CriteriaQuantity Limits
    • Absolute neutrophil count (ANC) must be ≥ 500 cells/mm³.
    • No toxic megacolon.
    • No small bowel ileus.
    Billing Rule

    Therapy Duration

    The maximum approvable length of Vowst therapy is 30 days.

    • Approve therapy for up to 30 days.
    Documentation Required

    EPSDT Documentation and Prior Approval

    For beneficiaries under 21, EPSDT may allow coverage beyond limits in the clinical policy when the provider documents that the service is medically necessary to correct or ameliorate an identified defect, illness, or condition and satisfies all EPSDT criteria. Being under 21 does not eliminate a prior-approval requirement.

    • Document the beneficiary’s condition, medical necessity, and how Vowst will improve, maintain, or prevent worsening of health.
    • Prior approval remains required when applicable, including for beneficiaries under 21.
    • EPSDT does not require coverage of services that are unsafe, ineffective, experimental/investigational, nonmedical, or not generally accepted medical practice.
    Denial Risk

    Failure to Meet Coverage Criteria

    Deny the request when the beneficiary does not meet the initial coverage requirements or when required treatment and preparation steps are not documented.

    • Beneficiary is younger than 18.
    • No confirmed recurrent CDI or fewer than 3 CDI episodes within 12 months.
    • Antibiotic treatment was not completed 2–4 days before Vowst initiation.
    • Required bowel preparation or other coverage documentation is missing.
    Denial Risk

    Safety Exclusion

    Deny coverage when any specified safety exclusion is present. The request is not approvable with ANC < 500 cells/mm³, toxic megacolon, or small bowel ileus.

    • ANC < 500 cells/mm³.
    • Toxic megacolon.
    • Small bowel ileus.
  1. Bowel preparation: Beneficiary will take 10 oz of magnesium citrate, or 250 mL polyethylene glycol electrolyte solution for patients with impaired kidney function, the evening prior to initiation of Vowst therapyEvening before Vowst initiation
  2. Safety exclusions: Beneficiary must not have absolute neutrophil count (ANC) below 500 cells/mm3, toxic megacolon, or small bowel ileusANC must not be <500 cells/mm3