CurrentAvMedPolicy N/A

Botulinum toxin Type A prior authorization (coverage criteria)

This form governs prior authorization and step-edit requests for botulinum toxin Type A products (onabotulinumtoxinA and incobotulinumtoxinA) for AvMed members; it specifies required documentation, clinical criteria by indication, dosing limits, and administrative submission requirements affecting prescribers and office staff.

Policy Summary

PayerAvMed

PolicyBotulinum toxin Type A prior authorization (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed, signed prior authorization form with required clinical documentation and dosing details; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400maximum adult cumulative dose

10u/kg or 340maximum pediatric cumulative dose

1-305-671-0200PA fax

8-12 wksbehavioral therapy trial

Coverage Criteria

Indication-specific approval criteria

Covered when ALL checked criteria for the selected diagnosis are met; documentation must be provided for each checked item.

Primary diagnosis requirement: Member must have ONE of the listed diagnoses (e.g., achalasia, internal anal sphincter disorder, chronic anal fissure, blepharospasm, cerebral palsy-related spasticity/contracture, cervical dystonia, CVA-related spasticity within 1 year, drooling in Parkinson’s disease, essential hand tremor failing oral agents, hand dystonia, hemifacial spasm, motor tics, neurogenic detrusor overactivity, orofacial dyskinesia, overactive bladder, strabismus, synkinetic eyelid closure, torticollis, etc.)1 of list

Provider must check applicable diagnosis on form.

Achalasia, Primary idiopathic esophageal: Member must meet ONE of the following: failed or had clinically significant adverse reaction to conventional therapy (nitrates or calcium channel blockers); ineligible for surgical treatment due to advanced age or multiple comorbidities (poor surgical risk); high risk of complications from pneumatic dilation or surgical myotomy; failure of prior myotomy or dilation; or presence of an epiphrenic diverticulum or hiatal hernia that increases risk of dilation-induced perforation.

Policy Summary

PayerAvMed

PolicyBotulinum toxin Type A prior authorization (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed, signed prior authorization form with required clinical documentation and dosing details; fax to 1-305-671-0200.

SourceLink

On This Page

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Achalasia, Internal anal sphincter (IAS): Member must meet BOTH of the following: has NOT responded to treatment with laxatives; AND has NOT responded to OR is NOT a candidate for anal sphincter myectomy.

Anal fissure - Chronic: Member must have failed at least 60 days of topical nitroglycerin or a topical calcium channel blocker.

Neurogenic detrusor overactivity (NDO) and/or detrusor sphincter dyssynergia: Member must have incontinence due to NDO or detrusor sphincter dyssynergia associated with a neurologic condition confirmed by urodynamic testing (submit documentation) AND meet age-specific medication trial requirements: for ages 5-17 years, a 30-day trial and failure of oxybutynin (oral or intravesical) and one other oral systemic agent from anticholinergics or beta-3 agonists; for members 17 years and older, a 30-day trial and failure of two oral systemic medications from anticholinergics or beta-3 agonists (submit chart notes documenting therapy failures).

Overactive bladder: Member must meet ALL of the following: diagnosis of incontinence with urge symptoms (at least 3 urinary incontinence episodes and at least 24 micturitions in 3 days); 8-12 week trial and failure of behavioral therapy (e.g., bladder training, pelvic floor muscle training, fluid management); failed or inadequate response to anticholinergic therapy within the last 9 months (4-8 week trial per agent); AND trial and failure of ONE of the specified medication regimens: either 2 anticholinergic agents plus 1 beta-3 adrenergic agonist (requires PA) OR 1 anticholinergic agent plus 1 alpha blocker plus 1 beta-3 adrenergic agonist (requires PA).

Other listed indications: For other diagnoses listed on the form (e.g., blepharospasm; cerebral palsy-related dynamic contracture or spasticity; cervical dystonia; CVA-related spasticity within 1 year; drooling in Parkinson’s; essential tremor failing oral agents; hand dystonia; hemifacial spasm; motor tics; orofacial dyskinesia; strabismus; synkinetic eyelid closure; torticollis), the specific checkboxes and any listed subcriteria on the form must be met and appropriate supporting documentation submitted.

Cosmetic uses of botulinum toxin Type A are not covered. Requests for indications intended primarily for cosmetic improvement should be declined per policy: Cosmetic indications are EXCLUDED.

Provider-collected or manufacturer-provided samples cannot be used to satisfy step-edit or prior therapy requirements. The policy explicitly states: Use of samples to initiate therapy does not meet step edit/ preauthorization criteria; prior therapies will be verified through pharmacy paid claims or submitted chart notes.

Coding and Dose Limits

Submission codesmixed

N/A	No specific CPT/HCPCS/ICD-10 codes listed on form; diagnosis ICD code to be provided if applicable

inv-05: Maximum cumulative dose (adult) — 400 units per 3-month period

Maximum cumulative dose (adult)400 units per 3-month period

Interval3-month period

ApplicabilityApplies to adult patients across indicated diagnoses

inv-06: Maximum cumulative dose (pediatric) — lower of 10 units/kg or 340 units per 3-month period

Maximum cumulative dose (pediatric)Lower of 10 units/kg body weight or 340 units per 3-month period

Interval3-month period

Dose basisWeight-based (10 units/kg) with absolute cap (340 units)

inv-07: Behavioral therapy trial duration for overactive bladder — 8-12 weeks required before botulinum therapy

Behavioral therapy trial duration8-12 weeks of behavioral therapy (e.g., bladder training, pelvic floor muscle training, fluid management)

RequirementRequired prior to botulinum toxin therapy for overactive bladder

DocumentChart documentation of the behavioral therapy trial and failure required

Provider Submission Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Requirement — A completed and signed prior authorization (PA) form with member and prescriber information and supporting clinical documentation is required. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid). Incomplete, incorrect, or illegible information may delay the authorization process.

Fax completed PA to 1-305-671-0200
Physician signature required; preprinted stamps not acceptable
Ensure phone and fax numbers on form are correct

Step Therapy

Samples and Step Edit Verification

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Prior therapies may be verified through pharmacy paid claims or must be documented in submitted chart notes.

Samples do not qualify as evidence of prior therapy
Provide documentation of failed or intolerant prior therapies (claims or chart notes)

Documentation Required

Required Submission Elements and Missing Clinical Documentation

Provide complete member and prescriber demographics and full drug information. Include prescriber signature, member name, AvMed ID, date of birth, prescriber name, NPI, office contact name, phone and fax numbers, diagnosis and ICD code (if applicable), drug name/form/strength, dosing schedule, length of therapy, weight (if applicable) and date weight obtained, and any applicable quantity limits. Attach supporting clinical documentation such as lab results, diagnostics, and chart notes for each criterion checked; missing documentation may result in denial.

Required: Member name, AvMed #, DOB
Required: Prescriber name, signature, date, NPI, office contact, phone, fax
Required: Drug name/form/strength, dosing schedule, length of therapy
Required: Diagnosis and ICD code (if applicable); weight and date weight obtained if relevant
Attach: Lab results, diagnostic reports, and clinic notes to support each checked clinical criterion
Note: Maximum quantity limits and cosmetic exclusions must be addressed in documentation (e.g., 400 units per 3-month period adult limit)

Background

Botulinum toxin Type A products are indicated for a range of neuromuscular and other conditions listed on the prior authorization form (for example, dystonias, spasticity, neurogenic detrusor overactivity, overactive bladder, achalasia, anal sphincter disorders, and others). Authorization requires that all checked clinical criteria for the selected diagnosis be met and supported by documentation (labs, diagnostics, chart notes). The form also specifies dosing limits: a maximum cumulative dose of 400 units per 3-month period for adults and, in pediatric patients, the lower of 10 units/kg or 340 units per 3-month period. For overactive bladder, behavioral therapy of 8–12 weeks and failure of specified medication regimens are among the required prerequisites.

Definitions

inv-14: Neurogenic detrusor overactivity (NDO) — definition and diagnostic confirmation requirements

DefinitionIncontinence due to neurogenic detrusor overactivity (NDO) or detrusor sphincter dyssynergia associated with a neurologic condition (e.g., multiple sclerosis, spinal cord injury, brain injury)

Diagnostic confirmationMust be confirmed by urodynamic testing; submit documentation of diagnosis

Age-specific medication trial requirementsAges 5-17: 30-day trial and failure of oxybutynin and one other oral systemic agent; Ages ≥17: 30-day trial and failure of two oral systemic medications from anticholinergics or beta-3 agonists (chart notes required)

Initial Therapy Criteria

Initial therapy requirements

Step requirements and trials prior to authorization for certain indications.

Overactive bladder prerequisites: Behavioral therapy trial of 8-12 weeks with failure documented (e.g., bladder training, pelvic floor muscle training, fluid management) AND failure or inadequate response to anticholinergic therapy within the last 9 months (4-8 week trial per agent).

Overactive bladder medication regimen trials: Member must have trial and failure of ONE of the following medication regimens: 1) two anticholinergic agents plus one beta-3 adrenergic agonist (this regimen requires prior authorization), OR 2) one anticholinergic agent plus one alpha blocker plus one beta-3 adrenergic agonist (this regimen requires prior authorization). Provider must indicate drugs used and submit documentation of trials and failures.

Neurogenic detrusor overactivity (NDO) prerequisites: For NDO, age-specific oral medication trials are required prior to authorization: ages 5-17 require a 30-day trial and failure of oxybutynin (oral or intravesical) and one other oral systemic agent from anticholinergics or beta-3 agonists; ages 17 and older require a 30-day trial and failure of two oral systemic medications from anticholinergics or beta-3 agonists. Chart notes documenting therapy failures must be submitted.

Samples and verification: Use of samples to initiate therapy does NOT meet step edit/preauthorization criteria; previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Step Therapy Requirements

Required prior trials / steps	Indication(s) / notes
8-12 week trial and failure of behavioral therapy (e.g., bladder training, control strategies, pelvic floor muscle training, fluid management)	Overactive bladder: required prior step before medication trials; behavioral therapy must be documented
Failed or inadequate response to anticholinergic therapy within the last 9 months (4-8 week trial per agent)	Overactive bladder: at least one anticholinergic trial required; timeframe and minimum duration specified
Trial and failure of ONE of the following medication regimens: 2 anticholinergic agents and 1 β-3 adenoreceptor agonist (requires PA)	Overactive bladder: alternative regimen option; prescriber must indicate drugs used
Trial and failure of ONE of the following medication regimens: 1 anticholinergic agent and 1 alpha blocker and 1 β-3 adenoreceptor agonist (requires PA)	Overactive bladder: alternative regimen option; prescriber must indicate drugs used
Use of samples to initiate therapy does not meet step edit/preauthorization criteria; prior therapies will be verified through pharmacy paid claims or chart notes	Applies to all indications subject to step therapy verification

Quantity Limits

inv-17: Botulinum toxin Type A (any covered product) — 400 units limit

Authorized product limitBotulinum toxin Type A (any covered product): maximum 400 units per 3-month period

Interval3-month period

Applies toAdult and general use unless pediatric-specific limit applies

inv-18: Botulinum toxin Type A (pediatric) — 10 units/kg or 340 units (whichever is lower)

Pediatric dosing capMaximum total dose for pediatric patients: lower of 10 units/kg or 340 units per 3-month period

Interval3-month period

DocumentationWeight and date weight obtained must be submitted when applicable

Site of Care

Note

Specify office or specialty pharmacy supply

Indicate on the form whether the medication will be provided by the physician's office or by a specialty pharmacy; either option is permitted as shown on the form.

Check 'Physician's office' or 'Specialty Pharmacy' on the form to specify site of medication provision.