Currentmedical mutual - ohioPolicy 082201

Botox® (onabotulinumtoxinA) prior authorization and dosing policy

Defines prior authorization, indication-specific clinical criteria, dosing/administration limits, renewal criteria, and billing codes (HCPCS J0585 and NDCs) for onabotulinumtoxinA (Botox) for multiple indications.

Policy Summary

Payermedical mutual - ohio

PolicyBotox® (onabotulinumtoxinA) prior authorization and dosing policy

Policy CodePolicy 082201

Change TypeNo material change

Effective DateAug 30, 2022

Next Review Date

Key ActionPrior approval is required for some or all procedure codes listed (J0585); authorization validity and renewal depend on meeting the universal and indication-specific criteria described.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

MultipleCovered Indications

J0585Primary HCPCS

2 NDCsProduct presentations

12Auth length (months)

1PA required (HCPCS)

150+

Coverage Summary

OnabotulinumtoxinA (Botox) is covered with indication-specific prior authorization criteria. The policy designates HCPCS J0585 as the primary billable code for onabotulinumtoxinA (1 billable unit = 1 unit) and lists product NDCs 00023-1145-xx and 00023-3921-xx. Authorization is typically issued for 12 months, and covered ICD-10 diagnoses are enumerated in Appendix 1 (multiple diagnoses across movement disorders, spasticity, migraine, bladder, hyperhidrosis, anal fissure, ventral hernia, TMD, etc.).

Quick facts & thresholds

Standard authorization length12 months

Primary HCPCS codeJ0585

Listed product presentationsBotox 100-unit (00023-1145-xx); Botox 200-unit (00023-3921-xx) — 2 NDCs

Adult cumulative dose limitNot to exceed 400 Units in a 3-month (12-week) interval

Retreatment intervalRe-treat no sooner than 12 weeks from prior injection

Initial Therapy Criteria

Initial Approval Criteria

Prior authorization validity is provided when ALL of the following universal and indication-specific criteria are met:

Indication-specific (ANY of the following indications with their criteria):

Blepharospasms: Patient is at least 12 years of age
Cervical Dystonia
- AND one of
  - sustained head tilt: Patient has sustained head tilt
  - abnormal posturing: Patient has abnormal posturing with limited range of motion in the neck

Renewal / Continuation Criteria

Renewal Criteria

Authorization may be renewed when ALL of the following are met:

Renewal top-level

Continued criteria: Patient continues to meet the universal and indication-specific criteria in Initial Approval Criteria
Duration of authorization has not been exceeded (refer to Length of Authorization: typically 12 months; preoperative ventral hernia use may not be renewed)
Safety: Absence of unacceptable toxicity from the drug (examples listed include symptoms of toxin spread, severe hypersensitivity, severe pulmonary effects, corneal exposure/ulceration, etc.)
AND disease response (one of the following per indication):

Prior Authorization & Billing Requirements

Prior approval required for J0585

Prior approval required for medical benefit coverage when ALL of the following apply:

Prior Approval Requirement

Service is billed with HCPCS code J0585
Diagnosis code is one of the covered ICD-10 codes in Appendix 1
Any applicable dual-coding requirements are met (see Dual coding requirement callout)
Documentation supporting medical necessity is available upon request

Provider Documentation & Monitoring

Documentation Required

Document baseline assessment for chronic migraine

Physicians must document baseline disease severity for chronic migraine using objective assessment tools and exclude other causes of headache prior to approval.

See provider_actions: Document baseline assessment for chronic migraine (HIT-6, MHD, MIDAS, MPFID)

Documentation Required

Document prior therapy failures for hyperhidrosis and OAB/detrusor overactivity

Document prior therapy failures as follows: for axillary hyperhidrosis (and palmar when applicable) document a ≥1 month trial of a topical agent; for palmar hyperhidrosis also document iontophoresis failure. For overactive bladder or neurogenic detrusor overactivity, document ≥1 month trials of two medications from antimuscarinic or beta‑adrenergic classes.

Applicable Codes

Background & Clinical Evidence

This corporate drug policy defines prior authorization requirements and provides indication-specific clinical criteria aligned with FDA-approved uses and compendia recommendations, includes dosing and administration guidance (indication-based dosing, re-treatment intervals, and cumulative dose limits), and cites clinical references and practice guidance to support coverage determinations.

Primary source: Botox package insert, Allergan (November 2023). Practice guidelines and systematic reviews referenced include multiple society guidelines and reviews (e.g., AAN, ACG, AUA, ASGE and headache, migraine, and other specialty guidance).

Definitions & Thresholds

Re-treatment interval: Unless otherwise stated, re-treatment should occur no sooner than 12 weeks from the prior injection.

Billable unit: For J0585, 1 billable unit = 1 unit of onabotulinumtoxinA.

NQTL: Non-quantitative treatment limitation (NQTL) refers to methods, guidelines, standards of evidence, or other conditions that can limit extent or duration of benefits (e.g., utilization review, prior authorization).

Thresholds

Chronic Migraine diagnostic threshold≥ 15 headache days/month for > 3 months; on ≥ 8 days/month headaches have migraine characteristics

Pediatric upper limb spasticity dosing limitsPer session: ≤ 6 U/kg or 200 U, whichever is lower; cumulative ≤ lower of 10 U/kg or 340 U in 3 months

Pediatric lower limb spasticity dosing limitsPer session: ≤ 8 U/kg or 300 U, whichever is lower; cumulative ≤ lower of 10 U/kg or 340 U in 3 months

Adult cumulative dose limit

Medicare Determinations & Local Coverage References

Medicare-related determinations and effective dates are documented; providers must follow applicable NCDs/LCAs/LCDs and local contractor rules listed in the policy. The policy lists multiple LCAs (e.g., A52848, A57186, A57474, A56472, A57185, A56646, A56389, A57715, A58423) with effective dates noted and advises that Medicare contractor rules and the referenced LCAs/NCDs must be followed for Medicare members.

Medicare Part B related LCAs/NCDs referencedmixed

A52848	Local Coverage Article: Billing and Coding: Botulinum Toxins (NGS) referenced
A57186	Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B (Noridian) referenced
A57474	Local Coverage Article: Billing and Coding: Botulinum Toxin Type A & Type B (WPS) referenced
A56472	Local Coverage Article: Billing and Coding: Botulinum Toxins (CGS) referenced
A57185	Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B Policy (Noridian) referenced
A56646	Local Coverage Article: Billing and Coding: Chemodenervation (Palmetto) referenced
A56389	Local Coverage Article: Billing and Coding: Upper GI Endoscopy (Palmetto) referenced
A57715	Local Coverage Article: Billing and Coding: Botulinum Toxins (First Coast) referenced
A58423	Local Coverage Article: Billing and Coding: Botulinum Toxins (Novitas) referenced

Revision History

2022-08-30Policy effective dateLatest

Policy effective date. Last review and next review dates are not provided in the document.

Policy Summary

Payermedical mutual - ohio

PolicyBotox® (onabotulinumtoxinA) prior authorization and dosing policy

Policy CodePolicy 082201

Change TypeNo material change

Effective DateAug 30, 2022

Next Review Date

Key ActionPrior approval is required for some or all procedure codes listed (J0585); authorization validity and renewal depend on meeting the universal and indication-specific criteria described.

On This Page

Strabismus: Patient is at least 12 years of age

Spastic Conditions: Patient has one of the following: Upper/Lower limb spasticity in adults; Pediatric upper limb spasticity in patients at least 2 years of age; Pediatric lower limb spasticity in patients at least 2 years of age; Spastic plegic conditions including Monoplegia, Diplegia, Hemiplegia, Paraplegia (including Hereditary spastic paraplegia) and Quadriplegia; Hemifacial Spasm

Severe Primary Axillary Hyperhidrosis: Patient has tried and failed ≥ 1 month trial of a topical agent (e.g., 20% aluminum chloride, glycopyrronium, aluminum zirconium trichlorohydrate, sofpironium, etc.); AND one of: history of medical complications such as skin infections or significant functional impairments OR significant burden of disease or impact to activities of daily living (e.g., impairment in work performance/productivity, frequent change of clothing, difficulty in relationships/social gatherings)

Prophylaxis for Chronic Migraines: Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., HIT-6, MHD, MIDAS, MPFID); Patient is utilizing prophylactic intervention modalities (avoiding triggers, pharmacotherapy, behavioral therapy, neuromodulation, physical therapy, etc.); Other causes of headaches have been ruled out; Diagnosis of chronic migraines defined as ≥ 15 headache days per month for > 3 months; On at least 8 days per month for > 3 months, headaches have characteristics and symptoms consistent with migraine

Esophageal Achalasia: One of: Patient is not a candidate for or has had treatment failure with definitive therapy (e.g., pneumatic dilation, surgical myotomy, POEM); Patient has had perforation from pneumatic dilation; Patient has an epiphrenic diverticulum or hiatal hernia; Patient has esophageal varices

Focal Dystonias: focal upper limb dystonia with functional impairment or pain; laryngeal dystonia; oromandibular dystonia with functional impairment or pain

Sialorrhea associated with Neurological Disorders: Sialorrhea: History of troublesome sialorrhea for at least a 3 month period; AND one of: Parkinson's disease OR severe developmental delays OR cerebral palsy OR amyotrophic lateral sclerosis (ALS)

Incontinence due to Detrusor Overactivity (neurogenic): Patient is at least 5 years of age; No current, untreated urinary tract infection; Detrusor overactivity associated with a neurologic condition confirmed by urodynamic testing; Failed a ≥ 1 month trial of two medications from either the antimuscarinic or beta-adrenergic classes

Overactive Bladder (OAB): No current, untreated urinary tract infection; Symptoms of urge urinary incontinence, urgency, and frequency; Failed a ≥ 1 month trial of two medications from either the antimuscarinic or beta-adrenergic classes

Severe Palmar Hyperhidrosis: Tried and failed ≥ 1 month trial of a topical agent (e.g., 20% aluminum chloride); Failed iontophoresis; AND one of: history of medical complications such as skin infections or significant functional impairments OR significant impact to activities of daily living due to condition

Chronic Anal Fissure: Other causes ruled out (e.g., Crohn's Disease); Failed non-pharmacologic supportive measures (sitz baths, psyllium fiber, bulking agents); Tried and failed ≥ 1 month trial of conventional pharmacologic therapy (oral/topical nifedipine, diltiazem, topical nitroglycerin, bethanechol, etc.)

Ventral Hernia (preoperative use in AWR): Ventral Hernia: Patient has a large ventral hernia with loss of domain or contaminated ventral hernia; Used preoperatively in patients scheduled to receive abdominal wall reconstruction (AWR)

Temporomandibular Disorders (TMD): Diagnosis of TMD with unilateral painful symptoms lasting > 3 months; Tried and failed a 3-month trial of conventional noninvasive therapy (CBT, pharmacotherapy, PT, occlusal devices, etc.)

Blepharospasms: Improvement of severity and/or frequency of eyelid spasms

Cervical Dystonia: Improvement in severity and frequency of pain and improvement of abnormal head positioning

Strabismus: Improvement in alignment of prism diopters compared to pre-treatment baseline

Upper/Lower Limb Spasticity: Decrease in tone and/or resistance based on a validated tool (e.g., Ashworth Scale, CGI)

Hemifacial Spasms: Decrease in frequency and/or severity of spasm or decrease in tone/improvement in asymmetry

Severe Primary Axillary Hyperhidrosis: Significant reduction in spontaneous axillary sweat production and improvement in ADLs

Prophylaxis for Chronic Migraines: Significant decrease in number/frequency/intensity of headaches on objective tool and improvement in function; continued use of prophylactic modalities

Esophageal Achalasia: Improvement/relief in symptoms or improvement in esophageal emptying by functional testing

Focal Dystonias: Improvement in pain and/or function (specifics by dystonia type)

Sialorrhea: Significant decrease in saliva production

Incontinence due to Detrusor Overactivity: No current untreated UTI; significant improvements in weekly incontinence frequency; periodic assessment of PVR as appropriate

Overactive Bladder: No current untreated UTI; significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided; periodic PVR assessment

Severe Palmar Hyperhidrosis: Significant reduction in spontaneous palmar sweat production and improvement in ADLs

Chronic Anal Fissure: Complete healing of anal fissure or symptomatic improvement of persistent fissures

Spastic Conditions, Other: Decrease in tone/resistance by validated tool

Temporomandibular Disorders: Significant improvement in symptoms

Prior Authorization

Prior authorization required for J0585

Prior authorization is required for medical benefit coverage for HCPCS J0585. Authorization is valid only when the prior approval criteria are met and documentation supports medical necessity. Medicare reference and applicability: where Medicare guidelines or billing rules apply to the member (e.g., Medicare Advantage), those rules are applicable in addition to this payer's prior authorization requirements.

Affected codes: J0585
Standard authorization length: 12 months

Billing Rule

Billing units and product NDCs

Report J0585 in units; 1 billable unit = 1 unit. When NDC reporting is required on the claim, include the appropriate product NDC. Note that single-dose vial presentations should be billed per vial/unit as appropriate.

Codes/NDCs: J0585
00023-1145-xx
00023-3921-xx
Note: single-dose vial presentations

Billing Rule

Dual coding requirement

Primary G and M diagnosis codes require a secondary G or I diagnosis code to be payable under the contract. Ensure claim line pairing follows payer and Medicare claim-line pairing rules where applicable; check claim submission rules for proper sequencing of primary and secondary diagnoses.

Dual coding requirement: primary G and M codes must be accompanied by a secondary G or I code
Recommendation: verify claim line pairing rules and Medicare applicability when submitting claims

Examples of agents/classes: antimuscarinics (darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium)

Examples of agents/classes: beta‑adrenergics (mirabegron, vibegron)

Documentation Required

Urodynamic confirmation for neurogenic detrusor overactivity

For neurogenic detrusor overactivity, urodynamic testing that confirms detrusor overactivity associated with a neurologic condition is required prior to approval.

Documentation Required

Adverse event monitoring for renewal

For renewal consideration, document the absence of unacceptable toxicity from onabotulinumtoxinA — including signs of toxin spread, severe hypersensitivity, severe pulmonary effects, corneal exposure/ulceration, and related serious adverse events.

Documentation Required

Documentation must support medical necessity

Providers must maintain and furnish documentation that supports medical necessity (patient records, test results, provider credentials) upon request. Claims may be denied if documentation is insufficient or the service is not medically necessary.

Not to exceed 400 Units in a 3-month (12-week) interval (unless Ventral Hernia)

Retreatment interval (general)No sooner than 12 weeks from the prior injection