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    OpenPayerPolicy UpdatesInfectious DiseaseHawaii DHS DAA Hepatitis C Prior Auth Update | Ope…
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    CurrentHawaii Department of Human ServicesPolicy QI-1829

    Direct Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection

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    Defines coverage criteria and guidance for use of FDA‑approved direct acting antiviral medications to treat chronic hepatitis C infection for Medicaid Fee‑For‑Service, QUEST Integration health plans, providers and pharmacies.

    Policy Summary
    PayerHawaii Department of Human Services
    PolicyDirect Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection
    Policy CodePolicy QI-1829
    Change TypeRevised eligibility and documentation requirements
    Effective DateDec 31, 2018
    Last ReviewDec 31, 2018
    Next Review Date
    Key ActionProvide prior authorization showing treatment follows an FDA‑approved DAA regimen and include a baseline quantitative HCV RNA obtained within the prior 3 months.
    SourceLink
    POLICY UPDATE CHANGES

    Patients with chronic HCV can be treated at any stage; the previous fibrosis (Metavir) restriction of F1 or greater has been removed.

    Sobriety restrictions have been removed; alcohol use and substance abuse are not absolute contraindications to DAA therapy.

    Treatment is allowed only in accordance with FDA‑approved regimens and requires a baseline quantitative HCV RNA within three months prior to treatment request.

    Specifies the prescriber types authorized to prescribe DAA therapy (hepatologist, gastroenterologist, infectious disease specialist, HIV specialist, or approved primary care physicians).

    3 monthsBaseline HCV RNA timing

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    All
    Eligible disease stages
    MultipleAuthorized prescriber types
    Appendix ARegimens listed

    Coverage Criteria for DAA Therapy

    Initial Therapy

    Treatment of chronic HCV with DAA medications may be covered when ALL of the following are met (subject to limitations/exclusions):

    Initial DAA treatment criteria: 1) Treatment is in accordance with FDA‑approved treatment regimens.
    Baseline HCV RNA: 2) Patient has chronic HCV infection and a baseline quantitative HCV ribonucleic acid (HCV RNA) result obtained within the previous three months of the request for treatment.within previous 3 months

    Baseline quantitative HCV RNA must be documented with the prior authorization request.

    Authorized prescriber: 3) Medication is prescribed by, or in consultation with, one of: hepatologist; gastroenterologist; infectious disease specialist; HIV specialist; or a primary care physician with hepatitis C expertise who is approved by the health plan.

    Consultation documentation required when applicable.

    Prescriber attestation of adherence: 4) Prescribing physician attests that the patient is compliant with treatment; evaluation of compliance should consider alcohol use and urine toxicology results, specialty pharmacy and appointment adherence, and laboratory follow‑up.

    Provider must document attestation in prior authorization materials.

    Address adherence‑impacting conditions: 5) Medical conditions that may impact adherence (including mental health conditions and substance abuse) have been addressed prior to starting treatment.

    Addressing does not preclude treatment; sobriety restrictions have been removed and substance use is not an absolute contraindication.

    Patients with life‑threatening medical conditions (for example, metastatic cancer) should have those conditions addressed prior to initiation of direct acting antiviral (DAA) therapy for chronic hepatitis C. Additionally, patients requiring highly specialized care — including decompensated cirrhosis, hepatocellular carcinoma, liver transplant candidates or recipients, other solid‑organ transplant candidates/recipients, or those with coinfection (hepatitis B or HIV) — should have DAA treatment directed by or in collaboration with a hepatologist or transplant facility. These considerations are required before DAA initiation to ensure appropriate management of concurrent life‑threatening illness and to optimize safety and outcomes.

    Prior restrictions that limited treatment eligibility by fibrosis stage have been removed: patients with chronic HCV can be treated at any stage and the previous Metavir fibrosis requirement (F1 or greater) is no longer required. In addition, formal sobriety requirements have been eliminated; alcohol use and substance abuse are not absolute contraindications to DAA therapy. Clinical assessment should still address factors that may affect adherence and outcomes, and complex cases should involve specialist input as noted in the policy.

    Testing and Coding Requirements

    inv-04: Baseline HCV RNA timing — within previous 3 months
    Required timingBaseline quantitative HCV RNA must be obtained within the previous three months of the treatment request.
    Test typeQuantitative HCV ribonucleic acid (RNA) assay.
    PurposeEstablish viral load prior to initiating FDA‑approved direct acting antiviral (DAA) therapy.
    Denial riskLack of a baseline quantitative HCV RNA within the prior three months may trigger denial of the request.

    Provider Requirements and Authorization

    Prior Authorization

    Prior authorization must show FDA regimen, recent baseline HCV RNA, authorized prescriber, and compliance attestation

    Prior authorization requests must document that treatment follows FDA‑approved DAA regimens and include a baseline quantitative HCV RNA obtained within the previous three months; requests should also show the prescriber is an authorized specialist or an approved primary care physician and include the prescriber’s attestation that the patient is compliant with treatment.

    • 1) Treatment is in accordance with FDA approved treatment regimens.
    • 2) Baseline quantitative HCV RNA result within the previous three months of request for treatment.
    • 3) Medication prescribed by, or in consultation with, an authorized specialist or approved PCP.
    • 4) Prescribing physician attests that the patient is compliant with treatment.
    Step Therapy

    No fibrosis floor or sobriety precondition for treatment

    There is no fibrosis-stage requirement and sobriety restrictions have been removed; step therapy based on Metavir fibrosis score or mandated sobriety is not required under this guidance.

    Definitions

    inv-10: Authorized prescriber — hepatologist, gastroenterologist, infectious disease specialist, HIV specialist, or qualified primary care physician
    Authorized prescriber typesHepatologist; Gastroenterologist; Infectious disease specialist; HIV specialist; Primary care physicians with expertise in hepatitis C who are approved by the health plan.
    Prescription requirementMedication must be prescribed by, or in consultation with, one of the authorized prescriber types listed.
    Plan approval for PCPsPrimary care physicians must have hepatitis C expertise and be approved by the health plan to qualify.
    inv-11: Baseline quantitative HCV RNA — quantitative HCV RNA obtained within three months prior to treatment request
    DefinitionA quantitative HCV ribonucleic acid (RNA) test result obtained within three months prior to the treatment request.
    Timing window

    Background

    Chronic hepatitis C virus (HCV) infection is treated with direct acting antiviral (DAA) medications that have transformed care by providing highly effective, well‑tolerated curative regimens across disease stages. Current guidance aligns treatment with FDA‑approved regimens and emphasizes coordination with appropriate specialists for complex patients. While DAAs are effective irrespective of fibrosis stage, prescribers should evaluate adherence, potential drug interactions, comorbid conditions, and the need for specialist management when planning therapy.

    Revision History

    2018-12-31policy_effectiveLatest

    Policy became effective (QI-1829) establishing coverage criteria for DAA therapy including alignment to FDA‑approved regimens and requirement for a baseline quantitative HCV RNA within 3 months.

    material_change

    Removed prior fibrosis (Metavir) restriction so patients with chronic HCV can be treated at any stage.

    material_change
    Policy Summary
    PayerHawaii Department of Human Services
    PolicyDirect Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection
    Policy CodePolicy QI-1829
    Change TypeRevised eligibility and documentation requirements
    Effective DateDec 31, 2018
    Last ReviewDec 31, 2018
    Next Review Date
    Key ActionProvide prior authorization showing treatment follows an FDA‑approved DAA regimen and include a baseline quantitative HCV RNA obtained within the prior 3 months.
    SourceLink
    On This Page
    Coverage Criteria for DAA TherapyTesting and Coding RequirementsProvider Requirements and AuthorizationDefinitionsBackgroundRevision History
    • The previous Metavir fibrosis score restriction (F1 or greater) has been removed.
    • Sobriety restrictions are removed; alcohol use and substance abuse are not absolute contraindications to DAA therapy.
    Documentation Required

    Documentation: prescriber attestation and consideration of alcohol/substance use

    Providers must document the prescriber’s attestation that the patient is compliant with treatment and that evaluation of compliance considered alcohol use and urine toxicology; also document baseline quantitative HCV RNA within three months and that treatment follows an FDA‑approved regimen.

    • Prescribing physician attests patient is compliant with treatment.
    • Evaluation of compliance should consider alcohol use and urine toxicology results.
    • Document baseline quantitative HCV RNA (within 3 months) and that DAA therapy follows an FDA‑approved regimen.
    Denial Risk

    Missing baseline quantitative HCV RNA may trigger denial

    Absence of a baseline quantitative HCV RNA result within the previous three months of the treatment request may result in denial of the prior authorization.

    • Ensure a quantitative HCV RNA test result is on file from within the prior three months before submitting the request.
    Within the previous three months of the request for treatment.
    Role in criteriaRequired as part of initial authorization for DAA therapy in accordance with policy inclusion criteria.

    Removed sobriety restrictions; alcohol use and substance abuse are not absolute contraindications to DAA therapy.

    addition

    Defined authorized prescribers to include hepatologist, gastroenterologist, infectious disease specialist, HIV specialist, and approved primary care physicians.