CurrentCapital BluecrossPolicy UM-278 (10/25/24)

OnabotulinumtoxinA (Botox) preauthorization requirements

Preauthorization form and clinical criteria for coverage of onabotulinumtoxinA (Botox) for multiple neurologic and non-neurologic indications; used by providers requesting prior authorization from Capital BlueCross/Prime Therapeutics.

Policy Summary

PayerCapital Bluecross

PolicyOnabotulinumtoxinA (Botox) preauthorization requirements

Policy CodePolicy UM-278 (10/25/24)

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax the completed preauthorization form (including HCPCS and diagnosis codes) to 866.805.4150 to request prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15+ indicationsdistinct diagnosis/indication sections

866.805.4150fax to submit form

UM-278internal identifier

includedage limits noted

Coverage Criteria

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Covered when ALL of the following are met

Coverage is considered when indication-specific criteria and required prior therapies/tests are documented. Many indications require failure of conservative or pharmacologic therapies and measurable clinical improvement for renewals.

General submission requirements: Provider submits preauthorization form with patient demographics, prescriber specialty or consultation documentation, HCPCS/diagnosis code(s), dosing and administration details, prior medication trials and reasons for discontinuation, and relevant testing (e.g., labs, imaging, urodynamics where applicable).

Supported by form fields and general instructions.

Indication-specific prior therapy: For many indications (examples listed on the form: chronic migraine, severe axillary hyperhidrosis, palmar hyperhidrosis, overactive bladder/detrusor overactivity), the patient must have tried and failed specified noninvasive or pharmacologic therapies for defined durations (examples on form: two oral preventive migraine agents each ≥8 weeks; >1 month topical trial for axillary hyperhidrosis; month-long trials of two medications for OAB).

See individual diagnosis sections on the form for exact required trials.

Age and diagnostic thresholds: Documented minimum age or diagnostic thresholds when applicable (examples from the form: chronic migraine defined as ≥15 headache days per month for >3 months; blepharospasm and strabismus ≥12 years of age; cervical dystonia ≥16 years of age; pediatric upper/lower limb spasticity ≥2 years of age; detrusor overactivity OAB criteria and urodynamic confirmation where specified).

Age and diagnostic thresholds are listed in each diagnosis section on the form.

Exclusion criteria: No active, untreated infection at the proposed injection site and no known hypersensitivity to botulinum toxin products. Concurrent treatment with another botulinum toxin should be disclosed as overlapping therapy may contraindicate coverage unless clinically justified.

Contraindications and concurrent therapy queries are included on the form.

Renewal criteria: For reauthorization, document clinically meaningful improvement specific to the treated indication (examples from the form: decreased frequency/severity of eyelid spasms for blepharospasm; improved head position and decreased pain for cervical dystonia; reduced headache frequency/intensity and improved function for chronic migraine; decreased weekly incontinence episodes for detrusor overactivity; decreased sweat production and improved activities of daily living for hyperhidrosis; decreased tone measured by validated tools for spasticity).

Renewal sections on the form specify the measure(s) of response required.

Coding and Clinical Thresholds

Requested HCPCS codesHCPCS

HCPCS code(s)

Requested HCPCS codes to be provided by the requester (document field)

Requested diagnosis codesICD-10

Diagnosis code(s)

Requested diagnosis/ICD-10 codes to be provided by the requester (document field)

inv-06: Chronic migraine frequency

Chronic migraine frequency>= 15 headache days per month for > 3 months

Migraine attack historyAt least five attacks with features consistent with migraine (with or without aura)

Migraine headache characteristicsOn at least 8 days per month for > 3 months headaches have characteristics consistent with migraines

inv-07: Pediatric age for spasticity

Pediatric spasticity age threshold>= 2 years for pediatric upper or lower limb spasticity

Adult spasticityUpper/lower limb spasticity in adults (e.g., post-stroke) — criteria applicable to adults

Other spastic conditions includedSpasticity due to multiple sclerosis, acquired spasticity from spinal cord/brain injuries, spastic plegic conditions

inv-08: Blepharospasm age

Blepharospasm minimum age>= 12 years

Strabismus age notePatient is at least 12 years of age for strabismus sections where specified

Renewal documentationRenewal requires documentation of improvement in severity and/or frequency of eyelid spasms (see renewal section)

inv-09: Cervical dystonia age

Cervical dystonia minimum age>= 16 years

Clinical features requiredHistory of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders

Functional impact measuresSustained head tilt or abnormal posturing with limited range of motion may be documented as part of criteria

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Submission

Fax the completed preauthorization form and all supporting documentation to 866.805.4150 (toll free).

Fax number: 866.805.4150
Use a separate form for each drug/request
Include all required attachments (test results, prior therapy documentation, specialist consults, etc.)

Denial Risk

Preauthorization Required

Preauthorization is required before services are rendered. Submission of a preauthorization request is not a guarantee of payment; claims may be denied if preauthorization is not obtained or if clinical criteria are not met.

Preauthorization must be obtained prior to administration when required by policy
A completed form and supporting clinical documentation are necessary for adjudication

Documentation Required

Dose and Off‑Label Documentation

Include documentation supporting any dose that differs from standard recommendations and any request for off‑label use. Reference Medical Policy 2.103 when requesting off‑label indications and attach rationale and supporting literature or clinical notes.

If dose exceeds FDA recommendations, provide justification and clinical evidence
Attach prior administrations records showing dose changes and clinical response
Cite relevant clinical guidelines or peer‑reviewed literature for off‑label uses

Step Therapy

Prior Therapy and Test Documentation

Provide documentation of prior therapies and trials as applicable to the requested indication. Include medications tried, duration, reason for discontinuation (e.g., intolerance, inadequate response, hypersensitivity), and results of relevant testing (labs, imaging, urodynamics, etc.).

List prior medications and strengths, dates, and reasons for failure
For OAB and neurogenic bladder, include urodynamic testing results and post‑void residual assessments
For hyperhidrosis, document topical/systemic therapy trials and outcomes

Background

OnabotulinumtoxinA (Botox) is requested across a broad range of neurologic and non-neurologic indications captured on the preauthorization form. These include movement disorders such as blepharospasm, cervical dystonia, and hemifacial spasm; spasticity (including pediatric limb spasticity); chronic migraine prophylaxis; focal and generalized dystonias; autonomic-related uses like hyperhidrosis (axillary, palmar), sialorrhea, and bladder disorders including detrusor overactivity/overactive bladder. The form collects indication-specific eligibility, prior therapy trials, age limits, dosing details, and measures of clinical response to support authorization decisions.

OpenPayer

OnabotulinumtoxinA (Botox) preauthorization requirements

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions & Submission Requirements

Background

Definitions