CurrentTexas Children's Health PlanPolicy 6175

Botulinum Toxin Injection Guidelines

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Guideline for Texas Children's Health Plan authorization of botulinum toxin injections, including documentation requirements, medically necessary indications, clinical criteria, and investigational, cosmetic, and not-medically-necessary uses.

Policy Summary

PayerTexas Children's Health Plan

PolicyBotulinum Toxin Injection Guidelines

Policy CodePolicy 6175

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for every botulinum toxin injection request with medical necessity, clinical effectiveness, dose, frequency, and injection-site documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Covered botulinum toxin products

12 weeksStandard injection interval

15+ days/monthChronic migraine threshold

6 monthsInitial migraine trial

7 days/month or 100 hours/month

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CurrentTexas Children's Health PlanPolicy 6175

Botulinum Toxin Injection Guidelines

Customize your policy alerts

Sign up for texaschildrenshealthplan Policy 6175 alerts

Get alerted when Policy 6175 changes without checking for updates manually.

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Policy Summary

PayerTexas Children's Health Plan

PolicyBotulinum Toxin Injection Guidelines

Policy CodePolicy 6175

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for every botulinum toxin injection request with medical necessity, clinical effectiveness, dose, frequency, and injection-site documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Covered botulinum toxin products

12 weeksStandard injection interval

15+ days/monthChronic migraine threshold

6 monthsInitial migraine trial

7 days/month or 100 hours/month

Continuation response

ExcludedCosmetic use

Medically Necessary and Excluded Uses

General medically necessary indications

Botulinum toxin may be considered medically necessary for the following indications.

Covered indications

Strabismus: Treatment of strabismus.
Spasticity- or dystonia-associated disorders: Treatment of blepharospasm, cerebral palsy, facial nerve (VII) dystonia, hemifacial spasm, hereditary spastic paraparesis, idiopathic torsion dystonia, multiple sclerosis, neuromyelitis optica, organic writer's cramp, orofacial dyskinesia or jaw-closure dystonia, Schilder's disease, spasmodic dysphonia or laryngeal dystonia, spastic hemiplegia, spasticity related to stroke, spinal cord injury, or traumatic brain injury, or symptomatic torsion dystonia when associated with spasticity or dystonia.
Other listed conditions: Treatment of other forms of upper motor neuron spasticity, essential tremor, achalasia, anal fissures, significant drooling, neurogenic overactive bladder, idiopathic overactive bladder in adults, functional obstruction caused by inability of the internal anal sphincter to relax in surgically treated Hirschsprung disease, or qualifying primary axillary, palmar, or gustatory hyperhidrosis.
Cervical dystonia: Treatment of moderate or greater severity cervical dystonia (spasmodic torticollis) when the applicable initial or continuation criteria are met.
Chronic migraine: Prevention of chronic migraine headaches when the applicable initial and continuation criteria are met.

Initial cervical dystonia therapy

Covered when ALL of the following are met.

Recurrent involuntary contractions: There is a history of recurrent clonic or tonic involuntary contractions of one or more of the sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.
Abnormal posture and limited motion: There is sustained head tilt or abnormal posturing with limited range of motion in the neck.
Duration: The condition has been present for greater than 6 months.> 6 months

Continuation cervical dystonia therapy

Covered when ALL of the following are met.

Documented response: Response to the initial botulinum toxin treatment is documented in the medical record.
Ongoing eligibility: The individual still meets the initial medical necessity criteria for cervical dystonia treatment.

Initial chronic migraine therapy

Covered for an initial 6-month trial when ALL of the following are met, including any 2 of the 3 medication classes.

Adult with chronic migraine: The individual is an adult diagnosed with chronic migraine headache.
Headache frequency and duration: The individual has 15 or more headache-days per month, with each headache lasting 4 hours or longer.>= 15 headache-days/month; headache duration >= 4 hours
History duration: The first episode occurred at least 6 months ago.>= 6 months
Prior preventive medication trials

Continuation chronic migraine therapy

Covered when ANY of the following response criteria are met after completion of the initial 6-month trial.

Reduced headache frequency: Migraine headache frequency was reduced by at least 7 days per month compared with the pretreatment average by the end of the initial trial.>= 7 fewer headache-days/month
Reduced headache duration: Migraine headache duration was reduced by at least 100 total hours per month compared with the pretreatment average by the end of the initial trial.>= 100 fewer headache-hours/month

Investigational, cosmetic, and not-medically-necessary uses

Not medically necessary or investigational uses.

Excluded uses

Cosmetic indication: Treatment of skin wrinkles or other cosmetic indications.
Nonqualifying headache: Treatment of tension headache, episodic migraine with 14 or fewer migraine days per month, chronic daily headache, or another headache other than qualifying chronic migraine.
Hirschsprung disease criteria not met: Treatment of Hirschsprung disease when the applicable functional obstruction and prior surgical treatment criteria are not met.
Post-failure treatment: Use of the same or a different botulinum toxin product following clinical failure of an initial trial for a medically necessary condition.

Skin wrinkles and other cosmetic indications are excluded because botulinum toxin used for these purposes is considered cosmetic and not medically necessary.

Treatment of headache disorders other than qualifying chronic migraine is excluded, including tension headache, episodic migraine with 14 or fewer migraine days per month, and chronic daily headache.

The specifically listed investigational conditions, conditions for which the applicable criteria are not met, and all other conditions not addressed by the medically necessary criteria are excluded. Examples include anismus, Behcet's syndrome, benign prostatic hyperplasia, carpal tunnel syndrome, fibromyalgia, gastroparesis, Parkinson's disease, Tourette's syndrome, tinnitus, tremors, vaginismus, and whiplash-related disorders.

Botulinum toxin for skin wrinkles or other cosmetic indications is considered cosmetic and not medically necessary.

Botulinum toxin for a headache disorder other than qualifying chronic migraine—including tension headache, episodic migraine with 14 or fewer migraine days per month, or chronic daily headache—is considered investigational and not medically necessary.

Use of the same or a different botulinum toxin product after clinical failure of an initial trial for a medically necessary condition is considered investigational and not medically necessary. This exclusion does not apply when the initial product was stopped because of product-specific intolerance or an allergic reaction rather than clinical failure.

Use for a listed condition when the applicable criteria are not met, or for any other condition not addressed by the guideline, is considered investigational and not medically necessary. The listed exclusions include conditions such as anismus, esophageal disorders not otherwise addressed, low back pain, myofascial pain syndrome, acquired nystagmus, sphincter of Oddi dysfunction, stuttering, urinary or anal sphincter dysfunction outside the listed covered indications, and zygomatic fractures.

Initial Therapy Requirements

Initial cervical dystonia therapy

Initial cervical dystonia therapy requires ALL of the following criteria.

Cervical dystonia

Recurrent contractions: There is a history of recurrent clonic or tonic involuntary contractions of the sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.
Posture and range of motion: There is sustained head tilt or abnormal posturing with limited range of motion in the neck.
Duration: The condition has been present for greater than 6 months.> 6 months

Continuation Therapy Requirements

Continuation therapy

Continuation therapy is covered when the applicable initial criteria remain satisfied and the required treatment response is documented.

Continuation pathways

Cervical dystonia continuation
- Documented response: Response to the initial botulinum toxin treatment is documented in the medical record.
- Continued criteria: The individual continues to meet the initial medical necessity criteria for cervical dystonia.
Chronic migraine continuation
- Required response

Required Previous Treatments

Indication	Required prior therapy	Requirement for botulinum toxin
Chronic migraine prevention	Trial of at least one preventive or migraine-frequency-reducing agent in each of any 2 classes: antidepressants, beta blockers, or antiepileptics	Symptoms persist despite the medication trials

Indication	Required prior therapy	Requirement for botulinum toxin
Significant drooling	Scopolamine or pharmacotherapy such as anticholinergics must be tried, or the individual must be unable to tolerate the therapy	Drooling is refractory to pharmacotherapy or scopolamine is not tolerated

Indication	Required prior therapy	Requirement for botulinum toxin
Neurogenic overactive bladder	Anticholinergic therapy	Symptoms are inadequately controlled with anticholinergic therapy
Idiopathic overactive bladder in adults	A trial of anticholinergic therapy	The individual is unresponsive to or intolerant of anticholinergic therapy

Indication	Required prior therapy	Requirement for botulinum toxin
Qualifying primary axillary, palmar, or gustatory hyperhidrosis	Topical aluminum chloride or other extra-strength antiperspirants	Topical therapy is ineffective and excessive sweating significantly disrupts social life

Dosing and Clinical Thresholds

Injection interval

Standard intervalEvery 12 weeks

Shorter intervalRequires documented medical necessity stating the need for an interval less than 12 weeks

Required request detailsProvide the injection dosage and frequency, clinical effectiveness, and specific injection site(s)

Cervical dystonia duration

ConditionModerate or greater severity cervical dystonia (spasmodic torticollis)

Duration thresholdThe condition has been present for greater than 6 months

Associated clinical finding

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all botulinum toxin injection requests. Submit requests to the Utilization Management Department through online submission, fax, phone, or mail during normal business hours.

All botulinum toxin injection requests require prior authorization.
Submission channels: online, fax, phone, or mail.
Requests are processed by Utilization Management during normal business hours.

Documentation Required

Authorization Submission Requirements

Authorization submissions must establish medical necessity and clinical effectiveness and specify the proposed dose, frequency, and injection site(s).

Support for medical necessity
Support for clinical effectiveness

Therapeutic Context

Botulinum toxins are potent neuromuscular blocking agents used to treat focal muscle spasticity, dystonia, spasms, twitches, and selected disorders involving excessive muscle contraction. They produce local chemical denervation by preventing acetylcholine release from nerve endings. Type A and type B products have distinct manufacturing processes and are not interchangeable; biological activity units cannot be converted between products.

Key Clinical Definitions

Botulinum toxins

DefinitionPotent neuromuscular blocking agents used to treat focal muscle spastic disorders and excessive muscle contractions, including dystonia, spasms, and twitches

MechanismProduce local chemical denervation by preventing the release of acetylcholine from nerve endings

Product distinctionType A and type B products are chemically, clinically, and pharmacologically distinct and are not interchangeable

Chronic migraine headache

FrequencyHeadache occurs on 15 or more days per month

DurationEach headache lasts 4 hours or longer

Policy Summary

PayerTexas Children's Health Plan

PolicyBotulinum Toxin Injection Guidelines

Policy CodePolicy 6175

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for every botulinum toxin injection request with medical necessity, clinical effectiveness, dose, frequency, and injection-site documentation.

SourceLink

On This Page

Antidepressants: At least one antidepressant, such as amitriptyline, nortriptyline, or doxepin, has been tried.

Beta blockers: At least one beta blocker, such as propranolol, timolol, or extended-release metoprolol, has been tried.

Antiepileptics: At least one antiepileptic, such as valproate, topiramate, or gabapentin, has been tried.

This exclusion does not apply when the initial product was stopped because of product-specific intolerance or allergic reaction rather than clinical failure.

Other excluded condition: Treatment of a listed condition when its criteria are not met, or treatment of any other condition not addressed as medically necessary by this guideline.

Initial chronic migraine therapy

Initial chronic migraine therapy requires ALL of the following criteria, including any 2 medication classes.

Chronic migraine initial trial

Preventive medication classes
- Antidepressants: At least one antidepressant has been tried.
- Beta blockers: At least one beta blocker has been tried.
- Antiepileptics: At least one antiepileptic has been tried.

Reduced headache frequency: Migraine headache frequency was reduced by at least 7 days per month compared with the pretreatment average.>= 7 fewer headache-days/month

Reduced headache duration: Migraine headache duration was reduced by at least 100 total hours per month compared with the pretreatment average.>= 100 fewer headache-hours/month

Sustained head tilt or abnormal posturing with limited range of motion in the neck

Chronic migraine frequency

Monthly frequency15 or more headache-days per month

Headache durationEach headache lasts 4 hours or longer

Treatment phaseApplies to the initial 6-month botulinum toxin trial

Chronic migraine history

History thresholdThe first episode occurred at least 6 months ago

Diagnosis requirementThe individual is an adult diagnosed with chronic migraine headache

Initial treatmentThe criterion applies to the initial 6-month trial

Migraine continuation response

Frequency responseReduction of at least 7 migraine headache-days per month compared with the pretreatment average

Duration responseReduction of at least 100 total headache-hours per month compared with the pretreatment average

TimingResponse is assessed by the end of the initial 6-month trial

Dosage and frequency of injections

Specific injection site(s)

Step Therapy

Drooling Pharmacotherapy Prerequisite

For significant drooling, document that the individual cannot tolerate scopolamine or that symptoms are refractory despite pharmacotherapy, such as anticholinergics.

Inability to tolerate scopolamine; or
Refractory symptoms despite pharmacotherapy, such as anticholinergics

Step Therapy

Neurogenic Overactive Bladder Prerequisite

For neurogenic overactive bladder, symptoms must be inadequately controlled with anticholinergic therapy.

Applies to neurogenic overactive bladder, including detrusor overactivity or detrusor sphincter dyssynergia.
Document inadequate control with anticholinergic therapy.

Step Therapy

Idiopathic Overactive Bladder Prerequisite

For idiopathic overactive bladder, the adult patient must be unresponsive to or intolerant of a trial of anticholinergic therapy.

Applies to adults with idiopathic overactive bladder.
Document unresponsiveness to or intolerance of an anticholinergic trial.

Step Therapy

Hyperhidrosis Treatment Prerequisite

For primary axillary, palmar, or gustatory hyperhidrosis, topical aluminum chloride or another extra-strength antiperspirant must be ineffective, and excessive sweating must have significantly disrupted social life.

Document ineffective topical aluminum chloride or another extra-strength antiperspirant.
Document significant disruption of social life due to excessive sweating.

Step Therapy

Chronic Migraine Medication Trials

For the initial six-month chronic migraine trial, symptoms must persist despite trials of at least one medication in any two required preventive or migraine-frequency-reducing classes.

Antidepressants, such as amitriptyline, nortriptyline, or doxepin
Beta blockers, such as propranolol, timolol, or extended-release metoprolol
Antiepileptics, such as valproate, topiramate, or gabapentin
At least one agent must have been tried in each of any two listed classes.

Documentation Required

Required Clinical Documentation

The clinical record supporting authorization must document the medical necessity and clinical effectiveness of treatment, including the planned dosage, frequency, and specific treatment site(s).

Medical necessity
Clinical effectiveness
Dosage
Injection frequency
Specific treatment site(s)

Documentation Required

Shortened Dosing Interval

Requests for botulinum toxin administration more frequently than every 12 weeks require documentation explaining the medical necessity for an interval shorter than 12 weeks.

Document why treatment at an interval of less than 12 weeks is medically necessary.

Documentation Required

Cervical Dystonia Continuation Documentation

For subsequent cervical dystonia injections, document the response to initial treatment and confirm that the individual continues to meet the applicable medical-necessity criteria.

Document response to initial treatment in the medical record.
Document continued fulfillment of the cervical dystonia criteria.

Documentation Required

Chronic Migraine Response Documentation

Continuing chronic migraine treatment requires completion of the initial six-month trial and documentation of the required response threshold.

Document completion of the initial six-month trial.
Document a reduction of at least 7 headache-days per month compared with the pretreatment average; or
Document a reduction of at least 100 total headache hours per month compared with the pretreatment average.

Denial Risk

Criteria Not Met or Excluded Indication

Requests that do not meet the established criteria, including treatment of a condition when criteria are unmet or a condition not addressed by the guideline, are investigational and not medically necessary. Such requests may be referred to a TCHP Medical Director or Physician Reviewer, and the Denial Policy may be followed.

Criteria not met
Condition not addressed by the guideline
Hirschsprung disease when the stated criteria are not met

Denial Risk

Cosmetic Use

Botulinum toxin for skin wrinkles or other cosmetic indications is cosmetic and not medically necessary.

Skin wrinkles
Other cosmetic indications

Denial Risk

Nonqualifying Headache Indication

Botulinum toxin is investigational and not medically necessary for headache conditions other than qualifying chronic migraine.

Tension headache
Episodic migraine, including 14 or fewer migraine days per month
Chronic daily headache
Other headache conditions that do not meet the chronic migraine criteria

Denial Risk

Failure of Initial Product

Use of the same or a different botulinum toxin product after failure of an initial trial for a medically necessary condition is investigational and not medically necessary. This exclusion does not apply when the initial product was stopped because of product-specific intolerance or an allergic reaction rather than clinical failure.

Applies after clinical failure of an initial botulinum toxin product.
Exception: product-specific intolerance or allergic reaction, rather than clinical failure.

Denial Risk

Listed Investigational Conditions

The following conditions are specifically listed as investigational and not medically necessary when treated with botulinum toxin, unless otherwise addressed by the medically necessary criteria.

Anismus (pelvic floor dyssynergia)
Behcet's syndrome
Benign prostatic hyperplasia
Brachial plexus palsy
Carpal tunnel syndrome
Chronic motor tic disorder
Disorders of the esophagus, except as listed in the medically necessary section
Epicondylitis
Fibromyalgia/fibromyositis
Gastroparesis
Low back pain
Myofascial pain syndrome
Neck pain not related to the conditions listed above
Acquired nystagmus
Parkinson's disease
Post-mastectomy reconstruction syndrome
Reynaud's syndrome
Sphincter of Oddi dysfunction
Stuttering
Tics associated with Tourette's syndrome
Tinnitus
Tourette's syndrome
Tremors
Urinary and anal sphincter dysfunction, except as listed in the medically necessary section
Vaginismus
Whiplash-related disorders
Zygomatic fractures

Note

Authorization Is Not a Benefit Guarantee

Preauthorization addresses medical necessity only; it does not guarantee benefits, eligibility, or payment. Approved services remain subject to benefit limitations and exclusions, and providers must comply with applicable state and federal requirements.

Authorization applies only to the medical necessity of the treatment or service.
Eligibility and payment are not guaranteed.
Benefit limitations and exclusions still apply.
Noncompliance may result in retrospective audit and potential financial recoupment.

The first episode occurred at least 6 months previously