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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAvMed Botox Prior Auth Coverage & Policy Update | …
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    CurrentAvMedPolicy Pub. 100-2

    Botox (onabotulinumtoxinA, J0585) — Prior Authorization and Clinical Criteria for Upper and Lower Limb Spasticity

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    Prior authorization and step-edit request form and clinical criteria for coverage of Botox (onabotulinumtoxinA, J0585) for treatment of upper limb spasticity (ULS) and lower limb spasticity (LLS) for AvMed members; applies to prescribing providers requesting authorization.

    Policy Summary
    PayerAvMed
    PolicyBotox (onabotulinumtoxinA) prior authorization and coverage criteria for ULS/LLS
    Policy CodePolicy Pub. 100-2
    Change TypeNo material change
    Effective Date
    Last ReviewSep 16, 2019
    Next Review Date
    Key ActionSubmit a completed, signed prior authorization form with required documentation via fax to 1-877-535-1391.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    400Adult 3-month limit
    10 U/kg or 340Pediatric 3-month limit
    J0585

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    HCPCS code
    1-877-535-1391Fax number

    Coverage Criteria for Botox (onabotulinumtoxinA)

    Initial authorization criteria for Botox (ULS/LLS)

    Covered when ALL of the following are met

    General requirements: Completed authorization form with prescriber signature and required member/prescriber details; documentation supporting each clinical criterion; prior authorization submitted via fax.

    Form and documentation must be legible and complete; supporting documentation (lab results, diagnostics, chart notes) must be provided for each checked line.

    Anatomic indication

    • Upper Limb Spasticity options: Single Arm Upper Limb Spasticity OR Both Arms Upper Limb Spasticity (select specific anterior/posterior target muscles and unit ranges listed on the form).

      Examples: Biceps Brachii 100-200 units divided in 4 sites; Flexor Carpi Radialis 12.5-50 units; Flexor Digitorum groups 30-50 units, etc.

    • Lower Limb Spasticity option: Lower Limb Spasticity with dosing divided among up to five muscles (example per-muscle ranges listed).

      Example muscle doses: Gastrocnemius medial/lateral 75 units each; Soleus 75 units; Tibialis Posterior 75 units; Flexor Halluces Longus 50 units; Flexor Digitorum Longus 50 units.

    Dosing limits: Adult cumulative dose must not exceed 400 Units in a 3-month interval; pediatric cumulative dose must not exceed the lower of 10 Units/kg body weight or 340 Units in a 3-month interval.Adults <= 400 Units per 3-month interval; Pediatrics <= lower of 10 U/kg or 340 U per 3-month interval

    Ensure per-muscle dosing and total for the interval comply with these limits.

    Cosmetic uses are explicitly excluded from coverage. The form states: Cosmetic indications are EXCLUDED, so requests solely for aesthetic purposes will not meet medical necessity criteria and should not be authorized.

    The policy specifies that use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies must be documented and will be verified through pharmacy paid claims or submitted chart notes; therefore, providing or relying on drug samples does not satisfy the requirement to demonstrate prior therapy.

    Coding and Dose Limits

    Covered HCPCS CodesHCPCSCovered
    J0585onabotulinumtoxinA
    inv-05: Maximum adult cumulative dose
    Maximum adult cumulative dose<= 400 Units per 3-month interval
    ApplicabilityApplies when treating adult patients for one or more indications; cumulative across all treated sites
    Interval definition3-month interval (per form guidance)
    inv-06: Maximum pediatric cumulative dose
    Maximum pediatric cumulative dose<= lower of 10 Units/kg body weight or 340 Units per 3-month interval
    ApplicabilityTotal pediatric dose calculated by body weight and capped at 340 Units per 3 months

    What Providers Must Do

    Prior Authorization

    Prior Authorization Required

    Prior Authorization Required for J0585 — Submit the completed form via fax with prescriber information. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid). Fax to 1-877-535-1391. For Medicare members, applicable NCDs/LCDs and Pub. 100-2 Chapter 15 §50 apply; additional indications may be covered at the plan's discretion.

    • J0585 (onabotulinumtoxinA)
    • Fax: 1-877-535-1391
    • Prescriber signature and printed name required
    Step Therapy

    Samples Not Acceptable for Initiation

    Use of samples to initiate therapy does not meet step-edit or preauthorization requirements. Previous therapies will be verified through pharmacy paid claims or submitted chart notes. Samples are not acceptable evidence of meeting prior-authorization or step-therapy requirements.

    Background

    Botulinum toxin type A (onabotulinumtoxinA, Botox) is used to reduce muscle spasticity in targeted upper and lower limb muscles. The authorization form directs providers to identify the anatomic targets (Upper Limb Spasticity or Lower Limb Spasticity) and to document dosing distribution among the specified muscles. The form also emphasizes dosing limits: adults must not exceed 400 Units in a 3-month interval, and in pediatric patients the total dose must not exceed the lower of 10 Units/kg or 340 Units in a 3-month interval, with suggested per‑muscle unit ranges provided on the form.

    Definitions

    inv-13: Upper Limb Spasticity (ULS)
    Indication (ULS)Upper Limb Spasticity — single arm or both arms (provider must check applicable box on form)
    Example target muscles (anterior arm)Biceps brachii (100–200 units divided in 4 sites); Flexor carpi radialis (12.5–50 units); Flexor carpi ulnaris (12.5–50 units); Flexor pollicis longus (20 units)
    Example target muscles (posterior arm)Flexor digitorum profundus (30–50 units); Flexor digitorum sublimis (30–50 units); Adductor pollicis (20 units)
    inv-14: Lower Limb Spasticity (LLS)
    Indication (LLS)Lower Limb Spasticity — dosing distributed among up to five muscles (provider must check applicable box on form)
    Typical distribution and total300–400 units divided among 5 muscles (total for lower limb)

    Initial Therapy

    Initial therapy

    Initial coverage when clinical criteria met

    Initial therapy requirements: Completed form with prescriber signature and required patient/prescriber details; documentation supporting the indicated anatomic targets and prior therapies; dosing within stated per-muscle ranges and overall 3-month limits.Adults <= 400 Units per 3-month interval; Pediatrics <= lower of 10 U/kg or 340 U per 3-month interval

    Previous therapies will be verified via pharmacy paid claims or submitted chart notes; samples used to initiate therapy do not satisfy step-edit/preauthorization requirements.

    Step Therapy Requirements

    RequirementNotes
    Previous therapies verified
    Verification will be performed via pharmacy paid claims or submitted chart notes; use of samples to initiate therapy does not satisfy the step-edit/preauthorization requirement.

    Quantity Limits

    inv-17: onabotulinumtoxinA (Botox) — 400 Units
    Drug (onabotulinumtoxinA)onabotulinumtoxinA (Botox) — 400 Units per 3-month interval maximum (adults)
    HCPCS codeJ0585 (onabotulinumtoxinA)
    Quantity limit description400 Units specified as the quantity limit per 3-month course on the form

    Site of Care

    Note

    Specify site of care — office or PropriumRx

    Indicate on the form whether the medication will be provided in the physician's office or via the specialty pharmacy (PropriumRx) as shown on the authorization form.

    • Check either 'Physician's office' or 'Specialty Pharmacy - PropriumRx' on the form.
    Policy Summary
    PayerAvMed
    PolicyBotox (onabotulinumtoxinA) prior authorization and coverage criteria for ULS/LLS
    Policy CodePolicy Pub. 100-2
    Change TypeNo material change
    Effective Date
    Last ReviewSep 16, 2019
    Next Review Date
    Key ActionSubmit a completed, signed prior authorization form with required documentation via fax to 1-877-535-1391.
    SourceLink
    On This Page
    Coverage Criteria for Botox (onabotulinumtoxinA)Coding and Dose LimitsWhat Providers Must DoBackgroundDefinitionsInitial TherapyStep Therapy RequirementsQuantity LimitsSite of Care
    Interval definition
    3-month interval (per form guidance)
    Documentation Required

    Supporting Documentation Required

    Supporting documentation must be provided for each clinical criterion checked. Provide relevant lab results, diagnostic studies, and chart notes that substantiate the diagnosis, severity, prior treatments, and functional impact. Requests lacking supporting documentation may be denied.

    • Include lab results, diagnostics, and chart notes as applicable
    • Documentation must specifically support each clinical criterion checked on the form
    Documentation Required

    Form Completion Requirements

    Complete all required fields on the authorization form to avoid delays or denial. Required information includes member name, AvMed ID number, date of birth, prescriber name, prescriber signature, date, office contact name, phone and fax numbers, and prescriber DEA or NPI. Also include drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight, and date. Cosmetic indications are excluded.

    • Member identifiers: name, AvMed #, DOB
    • Prescriber: name, signature (hand-signed), date, DEA or NPI
    • Contact: office contact name, phone, fax
    • Clinical: drug form/strength, dosing schedule, length of therapy, diagnosis and ICD-10 code, weight, date
    Denial Risk

    Incomplete Documentation Risks Denial

    Incomplete, incorrect, or illegible forms and missing documentation may result in delays or denial of the request. Ensure all fields are completed, signatures are hand-signed, and supporting records are attached; otherwise authorization can be delayed or denied.

    • Incomplete/illegible/incorrect forms risk denial or delay
    • Attach supporting records to substantiate each criterion
    Example muscle-specific dosesGastrocnemius medial head (75 units); Gastrocnemius lateral head (75 units); Soleus (75 units); Tibialis posterior (75 units); Flexor hallucis longus (50 units); Flexor digitorum longus (50 units)