Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida Medicaid ARIKAYCE Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    ARIKAYCE Prior Authorization Criteria

    Customize your policy alerts

    Sign up for all Agency for Health Care Administration policy alerts

    Know when Agency for Health Care Administration releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Prior authorization coverage criteria for ARIKAYCE (amikacin liposome inhalation suspension) in adults with refractory Mycobacterium avium complex lung disease.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyARIKAYCE Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization with laboratory documentation showing failure to achieve negative sputum cultures after at least 6 consecutive months of multidrug treatment.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Up to 1 yearMaximum authorization duration
    ≥18 yearsMinimum patient age
    6 monthsPrior multidrug treatment
    590 mg once dailyDosing regimen

    Coverage 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.

    Initial Therapy

    Covered when all of the following are met:

    Initial ARIKAYCE authorization criteria

    • Patient eligibility: Patient is at least 18 years of age≥ 18 years
    • Confirmed diagnosis: Patient has a confirmed diagnosis of refractory Mycobacterium avium complex (MAC) lung disease
    • Prescriber qualification: Prescriber is a pulmonologist or infectious disease specialist
    • Prior treatment failure: Patient has failed to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug treatment regimenAt least 6 consecutive months

      Laboratory documentation required

    • Combination therapy: ARIKAYCE will be part of a combination antibacterial drug regimen

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for ARIKAYCE. When all review criteria are met, approval may be issued for up to one year.

    Documentation Required

    Sputum Culture Documentation Required

    Submit laboratory documentation demonstrating that the patient failed to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug treatment regimen.

    • Documentation required: Laboratory results showing persistent positive sputum cultures after the specified treatment duration.
    Denial Risk

    Failure to Meet Review Criteria

    Authorization may be denied or remain unsupported when any review criterion is not met. Confirm all of the following before submitting the request:

    • Patient is 18 years of age or older.
    • Patient has a confirmed diagnosis of refractory Mycobacterium avium complex (MAC) lung disease.
    • Prescriber is a pulmonologist or infectious disease specialist.
    • Patient has failed to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug treatment regimen, with laboratory documentation.
    • ARIKAYCE will be used as part of a combination antibacterial drug regimen.

    Clinical Definition

    Refractory MAC lung disease
    ConditionMycobacterium avium complex (MAC) lung disease that has not responded adequately to prior treatment
    Treatment response standardFailure to achieve negative sputum cultures
    Required prior treatment durationAt least 6 consecutive months of multidrug therapy

    Initial Therapy

    Initial Therapy

    Covered when all of the following are met:

    Initial ARIKAYCE criteria

    • Age: Patient is at least 18 years of age≥ 18 years
    • Diagnosis: Patient has confirmed refractory Mycobacterium avium complex (MAC) lung disease
    • Prescriber specialty: Prescriber is a pulmonologist or infectious disease specialist
    • Prior multidrug regimen failure: Patient failed to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug treatment regimenAt least 6 consecutive months

      Laboratory documentation required

    • Combination regimen: ARIKAYCE will be used as part of a combination antibacterial drug regimen

    Required Prior Treatment

    StepPrior treatment requirementFailure criterion
    1Patient must have received and failed a multidrug treatment regimen before ARIKAYCE authorization, for a minimum of 6 consecutive months.Failed to achieve negative sputum cultures; laboratory documentation is required.

    Dose and Quantity Limits

    ARIKAYCE quantity limit
    Strength per vial590 mg
    Volume per vial8.4 mL
    Administration limitContents of one vial administered once daily
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyARIKAYCE Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization with laboratory documentation showing failure to achieve negative sputum cultures after at least 6 consecutive months of multidrug treatment.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation RequirementsClinical DefinitionInitial TherapyRequired Prior TreatmentDose and Quantity Limits