CurrentAnthemPolicy CC-0032

Botulinum Toxin — Clinical Coverage Criteria

Clinical coverage criteria, quantity limits, and authorized indications for botulinum toxin products (e.g., Botox, Dysport, Xeomin, Daxxify, Myobloc) used under the medical benefit for Anthem members.

Policy Summary

PayerAnthem

PolicyBotulinum Toxin — Clinical Coverage Criteria

Policy CodePolicy CC-0032

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization to confirm the member meets the listed diagnostic and clinical criteria and that requested units do not exceed per‑indication or cumulative limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 unitsadult 3‑month cap

≤10 U/kg or 340 Upediatric 3‑month cap

155 unitschronic migraine typical

12 weeksminimum dosing interval

NCapplicable state

Coverage Criteria for Botulinum Toxin Products

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inv-01: Appropriate/Medically Necessary Indications

Requests for botulinum toxin may be approved when ALL of the following applicable diagnostic and clinical criteria are met:

Cervical dystonia - initial treatment: Individual has cervical dystonia (spasmodic torticollis) of moderate or greater severity; AND is requesting initial treatment; AND has recurrent clonic or tonic involuntary contractions of one or more specified neck muscles (sternocleidomastoid, splenius, trapezius or posterior cervical muscles); AND has abnormal posturing/limited neck range of motion or sustained head tilt; AND duration of condition is greater than 6 months

Policy II–VI

Cervical dystonia - subsequent injections: Individual has cervical dystonia of moderate or greater severity; AND is requesting subsequent injections; AND there is clinically significant improvement or stabilization in clinical signs and symptoms

Policy VII–IX

Chronic migraine - initial treatment: Individual has chronic migraine AND is requesting initial treatment AND meets frequency criteria: ≥15 headache-days per month for >3 months with at least 8 days per month having features of migraine (ICHD-3)≥15 headache-days/month for >3 months; ≥8 migraine-feature days/month

Policy X–XII

Chronic migraine - concurrent CGRP agent: If individual is concurrently using a CGRP agent and plans to use both CGRP and botulinum toxin together (not switching), the individual must have had a reduction in overall migraine days or severe migraine days with the CGRP agent AND continue to have a significant number of migraine days or severe migraine days requiring additional preventive therapy

Policy XIII A–B

Chronic migraine - continuation: For continued treatment after the initial 6-month trial, individual must have completed the initial 6-month trial and demonstrate clinical benefit (examples include 50% reduction in frequency of headache/migraine days, significant decrease in attack duration or severity, improved response to acute treatment, reduced disability or improved quality of life) or other benefit deemed significant by the individual or prescriberClinical benefit (e.g., 50% reduction in frequency) after initial 6 months

Policy XII–XIII

Primary hyperhidrosis: Individual has primary hyperhidrosis AND has failed a 6-month trial of one or more non-surgical treatments (e.g., topical aluminum chloride, anticholinergics, etc.) AND has either medical complications/skin maceration with secondary infection OR significant functional impairment (frequent interference with daily activities)6-month trial failure

Policy XVII–XIX

Secondary hyperhidrosis related to surgical complications: Individual has secondary hyperhidrosis related to surgical complications AND has either medical complications/skin maceration with secondary infection OR significant functional impairment (frequent interference with daily activities)

Policy XX–XXII

Other listed approvable indications: Individual has another listed approvable indication such as achalasia, anal fissure, significant drooling intolerant of anticholinergics, idiopathic or neurogenic overactive bladder with inadequate response/intolerance to anticholinergic or beta-3 agonist therapy, Hirschsprung disease with functional obstruction after prior surgical treatment, or other specified indications in the policy

See policy section I.B–F and related items

inv-02: Per-indication quantity and frequency limits

Covered when dosing, frequency, and total units do not exceed the following per-indication limits (and cumulative 3-month caps):

Adult cumulative limit: Total cumulative dose for all indications in any 3-month interval must not exceed 400 units for adults400 units/3 months

Policy cumulative limit applies across indications

Pediatric cumulative limit: Total cumulative dose for all indications in any 3-month interval must not exceed the lesser of 10 units/kg or 340 units for pediatric patients<= min(10 units/kg, 340 units)/3 months

Policy pediatric cumulative cap

Blepharospasm (Botox/Xeomin/Dysport): Botox (onabotulinumtoxinA): limit per indication 200 units as frequently as every 12 weeks; Xeomin (incobotulinumtoxinA): initial 25 units per eye (50 units total), dose should not exceed 100 units per session as frequently as every 12 weeks; Dysport (abobotulinumtoxinA): 120 units per eye (300 units) as frequently as every 12 weeks

Requests for botulinum toxin for cosmetic indications (e.g., treatment of skin wrinkles) and for headache diagnoses other than chronic migraine (for example, tension-type or episodic migraine with ≤14 migraine days/month, or chronic daily headaches) are excluded. In addition, treatments for any diagnosis not listed as an approvable indication — including, but not limited to, anismus (pelvic floor dyssynergia); benign prostatic hyperplasia; brachial plexus palsy; carpal tunnel syndrome; chronic motor tic disorder; fibromyalgia; gastroparesis; low back pain; myofascial pain syndrome; neck pain not related to listed conditions; nystagmus; Parkinson’s disease; tinnitus; Tourette’s-related tics; urinary or anal sphincter dysfunction (unless specifically listed as approvable); vaginismus; whiplash-related disorders; and zygomatic fractures — are not approvable under this policy.

The procedure, diagnosis, and device codes listed in this policy are provided for informational purposes only. Inclusion or omission of a code does not guarantee member coverage or provider reimbursement; providers must refer to the member’s contract benefits in effect at the time of service to determine coverage.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

Treatments requested for conditions explicitly listed as not approvable in the exclusions (for example, cosmetic uses, headache diagnoses other than chronic migraine, or any diagnosis not listed as approvable) are considered not medically necessary and may be denied.

Coverage for any procedure, diagnosis, or drug is conditioned on adherence to the policy’s per‑indication dosing, frequency, and cumulative quantity limits and is also subject to the member’s contract and benefit terms. Providers should document the indication and dose administered and verify member benefits when submitting requests.

Coding, Dose Limits, and Diagnostic Criteria

Product referencesmixed

N/A	Document identifies product names (Botox, Dysport, Xeomin, Myobloc, Daxxify) but specific CPT/HCPCS codes are not included in this excerpt.

CPT procedure codesCPT

46505	Laryngoscopy, flexible; with therapeutic injection(s) (eg, chemodenervation agent or corticosteroid)
52287	Cystourethroscopy, with injection(s) for chemodenervation of the bladder
64611	Chemodenervation of parotid and submandibular salivary glands, bilateral
64612	Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm or hemifacial spasm)
64615	Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine)
64616	Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis)
64617	Chemodenervation of muscle(s); larynx, unilateral, percutaneous, (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed
64642	Chemodenervation of one extremity; 1-4 muscle(s)
64643	Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s)
64644	Chemodenervation of one extremity; 5 or more muscles

1–10 of 16

1/2

HCPCS codesHCPCS

J0585	Injection, onabotulinumtoxinA, 1 unit [e.g., Botox]
J0586	Injection, abobotulinumtoxinA, 5 units [Dysport]
J0587	Injection, rimabotulinumtoxinB, 100 units [Myobloc]
J0588	Injection, incobotulinumtoxinA, 1 unit [Xeomin]
J0589	Injection, daxibotulinumtoxina-lanm, 1 unit [Daxxify]
S2340	Chemodenervation of abductor muscle(s) of vocal cord
S2341	Chemodenervation of adductor muscle(s) of vocal cord

ICD-10 diagnosis codes (selected examples)ICD-10

G24.5	Blepharospasm
G24.3	Spasmodic torticollis
G35.A-G35.D	Multiple sclerosis (specified codes listed)
G43.001-G43.919	Migraine
K22.0	Achalasia of cardia (cardiospasm)
K60.0-K60.2	Anal fissure
L74.510-L74.519	Primary focal hyperhidrosis
M62.40-M62.49	Contracture of muscle
N32.81	Overactive bladder (detrusor muscle hyperactivity)
Q43.1	Hirschsprung's disease

Package inserts and drug information sourcesmixed

No codes listed

Chronic migraine frequency — key diagnostic threshold

Chronic migraine frequency (diagnostic threshold)≥15 headache-days per month for >3 months with ≥8 days per month having features of migraine (ICHD-3)

Documentation required for initial requestRecord headache frequency (≥15 days/month for >3 months) and ≥8 migraine-feature days/month

Continuation requirementAfter an initial 6-month trial show reduction in migraine days or other clinically significant benefit (examples: 50% reduction in frequency, decreased duration/severity, improved function)

Adult cumulative 3-month dose cap

Adult cumulative 3-month dose cap400 units total cumulative dose for all indications in a 3-month interval (adults)

Typical per-indication exampleChronic migraine typical limit: 155 units as frequently as every 12 weeks

Follow product instructionsAdhere to indication-specific dosing and administration per package insert and policy limits

Pediatric cumulative 3-month dose cap

Pediatric cumulative 3-month dose cap (policy)Lesser of 10 units/kg or 340 units total cumulative dose in a 3-month interval (pediatrics)

Per-indication pediatric limits (examples)Upper limb: 3–6 units/kg (max 200 units) every 12 weeks; Lower limb: 4–8 units/kg (max 300 units) every 12 weeks

Apply product-specific maximaPer-indication maximums may further restrict dosing; follow package insert and policy limits

Pediatric cumulative dose cap — alternate references

Pediatric cumulative dose cap (alternate reference)Policy repeats: pediatrics — lesser of 10 units/kg or 340 units in a 3-month interval

Pediatric per-indication maxima citedExamples: upper limb max 200 units; lower limb max 300 units (Botox pediatric dosing)

Dosing intervalAs frequently as every 12 weeks for many pediatric spasticity indications

Adult cumulative dose cap — alternate references

Adult cumulative dose cap (alternate reference)Policy states adults should not exceed 400 units total in any 3-month interval

Per-indication examplesCervical dystonia and some spasticity indications list maxima up to 400 units per 12 weeks

Common dosing intervalMany indications permit repeat dosing as frequently as every 12 weeks (3 months)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Unit Limits

Prior authorization is required for botulinum toxin. Requests must include the diagnosis, clinical criteria met, and requested units per indication. Unit requests will be reviewed against indication-specific limits and cumulative caps (see Quantity Limits). Providers should confirm dosing follows indication-specific administration recommendations and that total dose in any 3-month interval does not exceed cumulative limits for adults and pediatric patients.

A. Prior authorization must document the specific approvable diagnosis and all supporting clinical information.
B. Specify units requested per indication and frequency (e.g., units per muscle, per treatment session, interval).
C. Total cumulative dose across all treated indications will be applied when reviewing authorization (adult max 400 units per 3 months; pediatrics = lesser of 10 units/kg or 340 units per 3 months).

Note

Prior Authorization — References Only

Some parts of this section reference supporting publications and product labeling rather than providing standalone prior authorization rules. These references inform clinical context and dosing guidance but do not replace the requirement to submit PA documentation as specified.

PREEMPT trials (PREEMPT 1 & 2) and professional society guidelines inform chronic migraine criteria.
DailyMed package inserts and DrugPoints provide product-specific dosing and vial information.

Documentation Required

Coverage Dependent on Member Contract

Inclusion or exclusion of codes, procedures, or diagnoses in this document does not guarantee coverage. Providers must verify coverage under the member's contract benefits in effect at the time of service.

Refer to the member’s contract to determine coverage or noncoverage for the requested service or drug codes (e.g., HCPCS J0585–J0589, S2340, S2341).
Coding listed is for informational purposes only; prior authorization approval and reimbursement depend on benefit design.

Documentation Required

Documentation and Member Contract

Providers must document the indication, dosage (units), muscles treated or injection sites, frequency/interval, prior treatments tried (when required by indication), and clinical response or benefit for continuation requests. For chronic migraine, include headache-day frequency and response during the initial 6-month trial.

Document initial and continuation criteria for chronic migraine: baseline headache-days (≥15/month for >3 months), and for continuation, documented clinical benefit after a 6-month trial (e.g., ≥50% reduction in headache frequency or other AHS-listed benefits).
For primary hyperhidrosis, document a failed 6-month trial of non-surgical treatments and presence of medical complications or significant functional impairment when required.
Verify member contract for any documentation or medical necessity requirements that affect coverage.

Note

Supporting References

Key supporting references include randomized controlled trials, professional society guidelines, and product labeling that underpin diagnosis-specific criteria and dosing limits. Review these sources when preparing prior authorization requests and when applying continuation criteria.

PREEMPT 1 & 2 trials for onabotulinumtoxinA in chronic migraine (Aurora et al.; Diener et al.).
American Headache Society consensus and practice guideline updates (AHS 2021; Simpson et al. Neurology 2016).
DailyMed package inserts and DrugPoints for product-specific dosing and vial information.

Step Therapy

Migraine Step Therapy Note

Note on migraine step therapy: step therapy for migraine prophylaxis agents was removed in the prior revision. When submitting requests for chronic migraine prophylaxis with botulinum toxin, do not apply step therapy requirements for CGRP or other migraine prophylactic agents; however, document prior therapies as requested for clinical context.

Policy update removed step through migraine prophylaxis agents (see Document History).
If concurrent use with a CGRP agent is requested, documentation must show additional benefit from combination therapy compared to monotherapy.

Note

No part of this publication may be reproduced, stored, or transmitted in any form without permission from the health plan.

Definitions and Trial Names

Spasticity — definition and clinical description

DefinitionSpasticity: a velocity-dependent increase in tonic stretch reflexes with exaggerated tendon jerks, typically associated with central nervous system injury; considered a subset of dystonia

Clinical featuresCharacterized by increased muscle tone, exaggerated reflexes, and impaired voluntary movement often after stroke, spinal cord injury, or traumatic brain injury

Relevance to treatmentBotulinum toxin can reduce muscle overactivity by inhibiting acetylcholine release at the neuromuscular junction; dosing tailored to severity and muscles involved

Non-interchangeability — potency/units are product-specific

Non-interchangeability statementBotulinum toxin agents are not interchangeable; potency units of one product cannot be converted to another

Product-specific dosingFollow the package insert for each product and use product-specific dosing; do not assume equivalent units across agents

Clinical implicationAuthorization and dosing limits apply per product labels and policy-specified maxima — verify product identity on requests

DP — DrugPoints off-label use/dosing reference

DP (DrugPoints) referenceDP = DrugPoints off-label use/dosing (policy references DrugPoints for off-label dosing guidance)

Use in policyDrugPoints listed among references for off-label use and dosing information

Location of sourceSee references: DrugPoints® System cited in document references

PREEMPT trials — Phase 3 trials for chronic migraine

PREEMPT trials (policy reference)PREEMPT 1 and PREEMPT 2: Phase 3 randomized, double-blind, placebo-controlled trials of onabotulinumtoxinA for chronic migraine cited in references

Primary citationsAurora et al., PREEMPT 1 (Cephalalgia 2010) and Diener et al., PREEMPT 2 (Cephalalgia 2010) included in references

Role in policyPREEMPT trials are listed among clinical literature supporting botulinum toxin use for chronic migraine

AUA/SUFU guideline — urology guideline documents referenced

AUA/SUFU guideline citationAUA/SUFU guideline on diagnosis and treatment of idiopathic overactive bladder and adult neurogenic lower urinary tract dysfunction is cited (Cameron et al.; Ginsberg et al.)

RelevanceGuidelines referenced to support urologic indications and management of overactive bladder in the policy

Reference detailsCameron AP et al.: The AUA/SUFU guideline (J Urol. Published online April 23, 2024); Ginsberg DA et al.: AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction (J Urol 2021)

OpenPayer

Botulinum Toxin — Clinical Coverage Criteria

Coverage Criteria for Botulinum Toxin Products

Coding, Dose Limits, and Diagnostic Criteria

Provider Actions, Prior Authorization, and Documentation

Clinical Background

Definitions and Trial Names