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Date Printed: December 16, 2017: 09:04 PM

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09-J0000-29

Original Effective Date: 10/15/99

Reviewed: 01/11/17

Revised: 11/15/17

Subject: Botulinum Toxins

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Botulinum toxin has been used for a wide variety of conditions in which the principal therapeutic aim is to reduce undesired or excessive contraction of striated or smooth (involuntary) muscle. There are three commercially available botulinum toxin type A preparations, onabotulinumtoxinA (Botox®), incobotulinumtoxinA (Xeomin®), and abobotulinumtoxinA (Dysport®), and one botulinum toxin type B preparation, rimabotulinumtoxinB (Myobloc®) available in the US. Because the potency of each botulinum toxin preparation is specific to the preparation and assay method, units of biologic activity for different preparations of botulinum toxin cannot be compared with or converted to units of other botulinum toxins. While therapy with botulinum toxin is relatively expensive considering the drug and administration costs and its effects are temporary and palliative (i.e., not curative) because of regeneration of nerve terminals in the affected muscle(s), treatment with botulinum toxin may provide an alternative to, or delay, more invasive and more costly interventions (e.g., surgery) and/or provide treatment for conditions for which few, if any, other effective therapies exist. Botulinum toxin also may be used in combination with other treatments to enhance efficacy. Because botulinum toxin prevents release of acetylcholine through denervation of cholinergic nerve terminals, the toxin also is used for autonomic disorders involving excessive glandular secretion (e.g., primary axillary hyperhidrosis) that is controlled by cholinergic transmission.

POSITION STATEMENT:

Initiation of botulinum toxin meets the definition of medical necessity when administered for the treatment of indications listed in Table 1 and ALL of the indication specific and maximum dose criteria are met:

TABLE 1:

Indications and Specific Criteria

Indication

Criteria

Maximum
Allowable Dose
(per 12 weeks)

Neurologic

Blepharospasm

When blepharospasm is characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle

Botox: 70 units (35 each eye)

[billing max of 100 units]

Xeomin: 70 units (35 each eye)

[billing max of 100 units]

Cervical dystonia (including spasmodic torticollis)

When ALL of the following are met:

• Cervical dystonia is associated with sustained head tilt OR abnormal posturing with limited range of motion in the neck

• Member has a history of recurrent, involuntary contraction of one or more of the muscles of the neck (e.g., sternocleidomastoid, splenius, trapezius, or posterior cervical muscles)

• Alternative causes of the member’s symptoms have been ruled out (e.g., chronic neuroleptic treatment, contractures, or other neuromuscular disorders)

• Duration of the condition is 6 months or more

Botox: 300 units

[billing max of 300 units]

Dysport:

• Initial: 500 units

[billing max of 500 units]

• Maintenance: 1000 units

• [billing max of 1000 units]

Myobloc: 5000 units

[billing max of 5000 units]

Xeomin: 300 units

[billing max of 300 units]

Essential tremor affecting the arms and/or hands

When ALL of the following are met:

• Member has had an inadequate response to at least 2 months of continuous treatment or has a contraindication to BOTH of the following:

o Propranolol (Inderal)

o Primidone (Mysoline)

• Member has had an inadequate response to at least 2 months of continuous treatment with ONE or more of the following (or has documented contraindications to ALL):

o Alprazolam (Xanax)

o Atenolol (Tenormin)

o Clonazepam (Klonopin)

o Gabapentin (Neurontin)

o Topiramate (Topamax)

o Sotalol (Betapace)

• Condition results in significant functional impairment (e.g., affects activities of daily living, including writing and eating) that is documented in the medical record

Botox: 200 units (100 each side)

[billing max of 200 units]

Xeomin: 200 units (100 each side)

[billing max of 200 units]

Focal dystonias

• Focal upper limb dystonia (e.g., organic writer’s cramp)

• Laryngeal dystonia (adductor/abductor spasmodic dysphonia)

Oromandibular dystonia

• Orofacial dyskinesia

• Cranial dystonia (Meige syndrome)

When EITHER of the following is met:

• Condition results in significant functional impairment (e.g., interference with joint function, mobility, communication, nutritional intake) that is documented in the medical record

• Member experiences pain as a result of the condition

Botox: 360 units

[billing max of 400 units]

Xeomin: 400 units

[billing max of 400 units]

Hemifacial spasm (seventh cranial nerve disorders)

Condition is characterized by sudden, unilateral, synchronous contractions of muscles innervated by the facial nerve

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Chronic migraine prophylaxis†

Initial 6 months when ALL of the following are met:

• Member is 18 years of age or older

• Member meets ALL of the following diagnostic criteria for chronic migraine:

o Member has headaches for 15 or more days per month, each headache lasts for 4 hours or more, and duration is greater than 3 months

o On at least 8 days (of the 15 days per month) per month for greater than 3 months, the headache is classified as migraine† with aura or without aura

ONE of the following:

o Member has had an inadequate response to at least 2 months of continuous treatment with a at least THREE medications selected from at least two of the following different classes of migraine prophylaxis medications:

- Non-SSRI antidepressants (e.g., amitriptyline, clomipramine, doxepin, mirtazapine, nortriptyline, venlafaxine)

- Antiepileptics (e.g., divalproex, gabapentin, topiramate)

- Beta-blockers (e.g., atenolol, metoprolol, nadolol, propranolol, timolol);

- Calcium channel blockers (e.g., diltiazem, nifedipine, nimodipine, verapamil)

o Member has had an inadequate response to at least 2 months of continuous treatment with a at least TWO medications selected from at least one class of migraine prophylaxis medications, AND has contraindications to the other three classes

o Member has contraindications to ALL four classes of medications

Botox: 155 units

[billing max of 200 units]

Xeomin: 200 units

[billing max of 200 units]

Spastic conditions affecting the upper or lower limbs

• Cerebral palsy

• Cerebrovascular accident (stroke)

• Spinal cord injury

• Traumatic brain injury

• Hereditary spastic paraplegia

• Multiple Sclerosis

Neuromyelitis optica

• Schilder’s disease

• Spastic hemiplegia

• Transverse myelitis

• Demyelinating diseases of CNS

When BOTH of the following are met:

EITHER of the following:

o Condition results in functional impairment (e.g., interference with joint function, mobility, communication, nutritional intake) that is documented in the medical record

o Member experiences pain as a result of the condition

• Surgical intervention is considered to be the last option

Dysport: 1500 units

[billing max of 1500 units]

Botox: 360 units

[billing max of 400 units]

Xeomin: 400 units

[billing max of 400 units]

Torsion dystonia

(including primary/genetic (idiopathic) and acquired (symptomatic))

When EITHER of the following is met:

• Condition results in functional impairment (e.g., interference with joint function, mobility, communication, nutritional intake) that is documented in the medical record

• Member experiences pain as a result of the condition

Botox: 360 units

[billing max of 400 units]

Xeomin: 360 units

[billing max of 400 units]

Exocrine

Palmar and axillary primary hyperhidrosis

When ALL of the following are met:

• Potential causes of secondary hyperhidrosis have been ruled out (e.g., hyperthyroidism)

• Condition is refractory to at least 2 months of continuous treatment with a topical agent (e.g., ≥20% aluminum chloride) unless use results in severe dermatitis

• Condition is refractory to at least 2 months of continuous treatment with conventional systemic pharmacotherapy (e.g., anticholinergics, beta blockers, or benzodiazepines) unless clinically contraindicated

EITHER of the following:

o The condition is associated with significant functional impairment that is documented in the medical record (e.g., member is unable to perform age-appropriate activities of daily living)

o The condition is causing persistent or chronic cutaneous conditions (e.g., skin maceration, dermatitis, fungal infections, secondary microbial infections)

Botox:

Palmar only: 100 units (50 units to each side)

[billing max of 100 units]

Axillary only: 100 units (50 units to each side)

[billing max of 100 units]

Both Palmar and Axillary: 200 units (50 units to each site, up to 4 sites)

[billing max of 200 units]

Xeomin:

Palmar only: 100 units (50 units to each side)

[billing max of 100 units]

Axillary only: 100 units (50 units to each side)

[billing max of 100 units]

Both Palmar and Axillary: 200 units (50 units to each site, up to 4 sites)

[billing max of 200 units]

Sialorrhea (excessive salivation)

When BOTH of the following are met:

• Member has ANY of the following conditions:

o Parkinson disease (PD)

o Amyotrophic lateral sclerosis (ALS)

o Cerebral palsy

• Member is refractory to at least 2 months of continuous treatment with at least one oral pharmacotherapy (e.g., anticholinergics)

Botox: 250 units (125 units to each parotid gland)

[billing max of 300 units]

Myobloc: 3000 units (1000 units to each parotid gland and 250 units to each submandibular gland)

[billing max of 5000 units]

Xeomin: 250 units (125 units to each parotid gland)

[billing max of 250 units]

Gustatory sweating

(e.g., Frey’s Syndrome, diabetic gustatory sweating)

When ALL of the following are met:

• Other potential causes of hyperhidrosis (e.g., hyperthyroidism) have been ruled out, or have been adequately treated

EITHER of the following:

o The condition is associated with significant functional impairment that is documented in the medical record (e.g., member is unable to perform age-appropriate activities of daily living)

o The condition is causing persistent or chronic cutaneous conditions (e.g., skin maceration, dermatitis, fungal infections, secondary microbial infections

• For gustatory sweating that is NOT Frey’s syndrome – member has had an inadequate response to treatment with at least 2 months of continuous treatment with a topical medication (e.g., ≥20% aluminum chloride or anticholinergic) unless use results in severe dermatitis

Botox: 65 units

[billing max of 100 units]

Xeomin: 65 units

[billing max of 100 units]

Gastrointestinal

Chronic anal fissure

When ALL of the following are met:

• Symptoms (e.g., nocturnal pain or bleeding, post-defecation pain) have persisted for 2 months or longer

• Member has had an inadequate response to at least ONE of the following topical treatments:

o Topical nitroglycerin

o Topical calcium channel blocker (e.g., diltiazem, nifedipine)

• Surgical intervention is considered to be the last option

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Esophageal achalasia

When ALL of the following are met:

• The member’s diagnosis has been confirmed by esophageal manometry (documentation must be provided)

EITHER of the following is met:

o Member has had an inadequate response to previous pneumatic dilation therapy or myotomy

o Member is considered a poor candidate for dilation/myotomy as evidenced by ONE or more of the following

- Sigmoid-shaped esophagus

- Previous dilation-induced perforation

- Epiphrenic diverticulum or hiatal hernia

- High risk for complications of myotomy or pneumatic dilation (e.g., member has esophageal reflux or perforation)

- Member has a limited life expectancy

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Hirschsprung disease

When ALL of the following are met:

• Member has obstructive symptoms caused by internal sphincter achalasia

• Member experienced symptoms following a pull-through surgery for their disease

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Ophthalmologic

Strabismus disorders in adults

When ALL of the following are met:

ONE or more of the following characteristics are present:

o Horizontal strabismus up to 50 prism diopters

o Vertical strabismus

o Persistent sixth nerve palsy of one month or longer

• Member has one or more of the following symptoms:

o Diplopia

o Impaired depth perception

o Impaired peripheral vision

o Impaired ability to maintain fusion

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Strabismus disorders in children (including infantile esotropia)

Diagnosis only

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Urologic

Urinary incontinence

When ALL of the following are met:

• Condition is due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury or multiple sclerosis) that has been confirmed by urodynamic testing

• Member has failure of behavioral therapy (e.g., bladder training, habit training, biofeedback, and pelvic muscle exercises)

EITHER of the following:

o Member has had an inadequate response to at least 2 months of continuous treatment with: (1) at least ONE prescription antimuscarinic (e.g., oxybutynin [Ditropan, Ditropan XL], tolterodine [Detrol, Detrol LA] solifenacin [Vesicare], trospium [Sanctura, Sanctura XR], darifenacin [Enablex], fesoterodine [Toviaz]) AND (2) mirabegron (Mybetriq)

o Member has a documented contraindication to both oral antimuscarinics AND mirabegron

Botox: 200 units

[billing max of 200 units]

Xeomin: 200 units

[billing max of 200 units]

Overactive bladder (OAB)

When ALL of the following criteria are met:

• Member has symptoms of urge urinary incontinence, urgency, or frequency

• Member has failure of behavioral therapy (e.g., bladder training, habit training, biofeedback, and pelvic muscle exercises)

EITHER of the following:

o Member has had an inadequate response to at least 2 months of continuous treatment with: (1) at least TWO prescription antimuscarinics (e.g., oxybutynin [Ditropan, Ditropan XL], tolterodine [Detrol, Detrol LA] solifenacin [Vesicare], trospium [Sanctura, Sanctura XR]) AND (2) mirabegron (Mybetriq)

o Member has documented contraindications to both oral antimuscarinics AND mirabegron

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Approval duration: 24 weeks

Diagnostic criteria for migraine with aura and without aura are located in the section entitled “OTHER.”

Continuation of botulinum toxin treatment meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has demonstrated a beneficial response to therapy.

2. For chronic migraine prophylaxis ONLY - Member has had a beneficial response to therapy as evidenced by EITHER of the following:

a. Headache frequency was reduced by 7 days per month or more (when compared to pre-treatment average) by the end of the initial trial

b. Headache duration was reduced by 100 total hours per month or more (when compared to pre-treatment average) by the end of the month

3. Authorization or reauthorization has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of for an indication listed in Table 1, OR the member previously met ALL indication-specific initiation criteria.

4. The dosage does not exceed the following based on the specific product and indication for use:

Indication

Maximum
Allowable Dose
(per 12 weeks)

Blepharospasm

Botox: 70 units (35 each eye)

[billing max of 100 units]

Xeomin: 70 units (35 each eye)

[billing max of 100 units]

Cervical dystonia (including spasmodic torticollis)

Botox: 300 units

[billing max of 300 units]

Dysport:

Initial: 500 units

[billing max of 500 units]

Maintenance: 1000 units

[billing max of 1000 units]

Myobloc: 5000 units

[billing max of 5000 units]

Xeomin: 300 units

[billing max of 300 units]

Essential tremor of arm and/or hands

Botox: 200 units (100 each side)

[billing max of 200 units]

Xeomin: 200 units (100 each side)

[billing max of 200 units]

Focal dystonias

• Focal upper limb dystonia (e.g., organic writer’s cramp)

• Laryngeal dystonia (adductor/abductor spasmodic dysphonia)

Oromandibular dystonia

• Orofacial dyskinesia

• Cranial dystonia (Meige syndrome)

Botox: 360 units

[billing max of 400 units]

Xeomin: 400 units

[billing max of 400 units]

Hemifacial spasm (seventh cranial nerve disorders)

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Chronic migraine prophylaxis

Botox: 155 units

[billing max of 200 units]

Xeomin: 200 units

[billing max of 200 units]

Spastic conditions affecting the upper or lower limbs

• Cerebral palsy

• Cerebrovascular accident (stroke)

• Spinal cord injury

• Traumatic brain injury

• Hereditary spastic paraplegia

• Multiple Sclerosis

Neuromyelitis optica

• Schilder’s disease

• Spastic hemiplegia

• Transverse myelitis

• Demyelinating diseases of CNS

Dysport: 1500 units

[billing max of 1500 units]

Botox: 360 units

[billing max of 400 units]

Xeomin: 400 units

[billing max of 400 units]

Torsion dystonia

(including primary/genetic (idiopathic) and acquired (symptomatic))

Botox: 360 units

[billing max of 400 units]

Xeomin: 360 units

[billing max of 400 units]

Palmar and axillary primary hyperhidrosis

Botox:

Palmar only: 100 units (50 units to each side)

[billing max of 100 units]

Axillary only: 100 units (50 units to each side)

[billing max of 100 units]

Both Palmar and Axillary: 200 units (50 units to each site, up to 4 sites)

[billing max of 200 units]

Xeomin

Palmar only: 100 units (50 units to each side)

[billing max of 100 units]

Axillary only: 100 units (50 units to each side)

[billing max of 100 units]

Both Palmar and Axillary: 200 units (50 units to each site, up to 4 sites)

[billing max of 200 units]

Sialorrhea (excessive salivation) due to Parkinson disease (PD), amyotrophic lateral sclerosis (ALS), or cerebral palsy

Botox: 250 units (125 units to each parotid gland)

[billing max of 300 units]

Myobloc: 3000 units (1000 units to each parotid gland and 250 units to each submandibular gland)

[billing max of 5000 units]

Xeomin: 250 units (125 units to each parotid gland)

[billing max of 250 units]

Gustatory sweating

(e.g., Frey Syndrome, diabetic gustatory sweating)

Botox: 65 units

[billing max of 100 units]

Xeomin: 65 units

[billing max of 100 units]

Chronic anal fissure

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Esophageal achalasia

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Hirschsprung disease

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Strabismus disorders in adults

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Strabismus disorders in children (including infantile esotropia)

Botox: 25 units

[billing max of 100 units]

Xeomin: 25 units

[billing max of 50 units]

Overactive bladder (OAB)

Botox: 100 units

[billing max of 100 units]

Xeomin: 100 units

[billing max of 100 units]

Urinary incontinence

Botox: 200 units

[billing max of 200 units]

Xeomin: 200 units

[billing max of 200 units]

Approval duration: 24 weeks

Botulinum toxin is considered experimental or investigational when administered for all other indications as additional controlled clinical trials are needed to demonstrate the safety and efficacy and there is insufficient clinical evidence to support it use, and specifically for the following:

The use of botulinum toxin administered for the treatment of skin wrinkles (e.g., glabellar creases, smoker’s lines, lipstick lines, crow’s feet, laugh lines, wrinkled neck, and aging neck) does NOT meet the definition of medical necessity, as they are considered cosmetic in nature and generally contract excluded.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Table 2:

FDA-approved indications† and Dosing

Product

FDA-approved Indications

Dose

Botox

Urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication

200 Units, as separate1 mL injections across 30 sites into detrusor

Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication

100 Units, as separate 0.5 mL injections across 20 sites into detrusor

Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

155 Units, as 0.1 mL injections per each site divided across 7 head/neck muscles

Lower limb spasticity in adults

300 to 400 Units divided among 5 muscles (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus and flexor digitorum longus)

Upper limb spasticity in adults

Dose is selected based on affected muscles, severity of muscle activity, prior response to treatment, and adverse event history. In clinical trials, doses ranging from 75 to 400 Units were divided among selected muscles.

Cervical dystonia in adults

Base dosing on the member's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history

Severe primary axillary hyperhidrosis in adults that is inadequately managed with topical agents

50 Units per axilla

Blepharospasm associated with dystonia (12 years of age and older)

1.25 Units to 2.5 Units into each of 3 sites per affected eye

Strabismus (12 years of age and older)

1.25 Units to 2.5 Units in any one muscle

Dysport

Cervical dystonia in adults

500 Units as a divided dose among affected muscles. Doses above 1000 Units have not been systematically evaluated.

Spasticity in adults (upper and lower limbs)

Dose is selected based on affected muscles, severity of muscle activity, prior response to treatment, and adverse event history. Dosing for upper limb spasticity is between 500 Units and 1000 Units and for lower limb spasticity is up to 1500 Units. The maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 Units.

Lower limb spasticity in pediatric patients (2 years to less than 18 years old)

Dose is selected based on affected muscles, severity of spasticity, and treatment history. Recommended dose is 10 to 15 units/kg per limb (not to exceed 15 units/kg for unilateral injection, 30 units/kg for bilateral injections, or 1000 units whichever is lower).

Myobloc

Cervical dystonia in adults

2,500 to 5,000 Units divided among affected muscles in members with a history of tolerating botulinum toxin injections; reduce dose in members without a prior history

Xeomin

Cervical dystonia in adults

120 Units per treatment session

Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox)

1.25 to 2.5 Units per injection site (50 Unit max per eye)

Upper limb spasticity in adults

Dose is selected based on affected muscles, severity of muscle activity, prior response to treatment, and adverse event history. In clinical trials, doses up to 400 Units were divided among selected muscles.

Indications related to cosmetic procedures (e.g., reduction in appearance of glabellar lines) are not provided in this table.

Drug Availability

PRECAUTIONS:

Boxed Warning:

An FDA MedWatch released on August 3, 2009 requires manufacturers of botulinum toxins A and B to include a Black Box Warning in the package insert describing the adverse effects of distant spread of botulinum toxic effects, including respiratory arrest and death, which are suggestive of systemic botulism. The symptoms have been reported hours to weeks after the injection.

Contraindications

All products

Botox

Dysport

Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J0585

Injection, onabotulinumtoxinA, 1 unit (Botox®)

J0586

Injection, abobotulinumtoxinA, 5 units (Dysport®)

J0587

Injection, rimabotulinumtoxinB, 100 units (Myobloc®)

J0588

Injection, incobotulinumtoxinA, 1 unit (Xeomin®)

ICD-10 Diagnoses Codes That Support Medical Necessity of Botox (J0585) and Xeomin (J0588):

G11.4

Hereditary spastic paraplegia

G24.1

Genetic torsion dystonia

G24.3

Spasmodic torticollis

G24.4

Idiopathic orofacial dystonia

G24.5

Blepharospasm

G24.8

Other dystonia

G25.89

Other specified extrapyramidal and movement disorders

G35

Multiple sclerosis

G36.0

Neuromyelitis optica

G37.0

Diffuse sclerosis of central nervous system

G37.1

Central demyelination of corpus callosum

G37.2

Central pontine myelinolysis

G37.3

Acute transverse myelitis in demyelinating disease of central nervous system

G37.5

Concentric sclerosis [Balo] of central nervous system

G37.8

Other specified demyelinating diseases of central nervous system

G37.9

Demyelinating disease of central nervous system, unspecified

G43.001 – G43.009

Migraine without aura, not intractable

G43.011 – G43.019

Migraine without aura, intractable

G43.101 – G43.109

Migraine with aura, not intractable

G43.111 – G43.119

Migraine with aura, intractable

G43.401 – G43.409

Hemiplegic migraine, not intractable

G43.411 – G43.419

Hemiplegic migraine, intractabl

G43.501 – G43.509

Persistent migraine aura without cerebral infarction, not intractable

G43.511 – G43.519

Persistent migraine aura without cerebral infarction, intractable

G43.601 – G43.609

Persistent migraine aura with cerebral infarction, not intractable

G43.611 – G43.619

Persistent migraine aura with cerebral infarction, intractable

G43.701 – G43.709

Chronic migraine without aura, not intractable

G43.711 – G43.719

Chronic migraine without aura, intractable

G43.801 – G43.809

Other migraine, not intractable

G43.811 – G43.819

Other migraine, intractable

G43.821 – G43.829

Menstrual migraine, not intractable

G43.831 – G43.839

Menstrual migraine, intractable

G43.901 – G43.909

Migraine, unspecified, not intractable

G43.911 – G43.919

Migraine, unspecified, intractable

G43.A0 – G43.A1

Cyclical vomiting

G43.B0 – G43.B1

Ophthalmoplegic migraine

G43.C0 – G43.C1

Periodic headache syndromes in child or adult

G43.D0 – G43.D1

Abdominal migraine

G44.221

Chronic tension-type headache, intractable

G44.229

Chronic tension-type headache, not intractable

G51.2

Melkersson's syndrome

G51.4

Facial myokymia

G51.8

Other disorders of facial nerve

G80.0 – G80.9

Cerebral palsy

G81.10 – G81.14

Spastic hemiplegia

G82.20 – G82.22

Paraplegia

G82.50 – G82.54

Quadriplegia

G83.0

Diplegia of upper limbs

G83.20 – G83.24

Monoplegia of upper limb

G83.4

Cauda equina syndrome

G83.81

Brown-Sequard syndrome

G83.82

Anterior cord syndrome

G83.89

Other specified paralytic syndromes

H02.049

Spastic entropion of unspecified eye, unspecified eyelid

H02.149

Spastic ectropion of unspecified eye, unspecified eyelid

H49.00 – H49.03

Third [oculomotor] nerve palsy

H49.10 – H49.13

Fourth [trochlear] nerve palsy

H49.20 – H49.23

Sixth [abducent] nerve palsy

H49.30 – H49.33

Total (external) ophthalmoplegia

H49.40 – H49.43

Total (external) ophthalmoplegia

H49.881 – H49.889

Other paralytic strabismus

H49.9

Unspecified paralytic strabismus

H50.00

Unspecified esotropia

H50.011 – H50.012

Monocular esotropia

H50.021 – H50.022

Monocular esotropia with A pattern

H50.031 – H50.032

Monocular esotropia with V pattern

H50.041 – H50.042

Monocular esotropia with other noncomitancies

H50.05

Alternating esotropia

H50.06

Alternating esotropia with A pattern

H50.07

Alternating esotropia with V pattern

H50.08

Alternating esotropia with other noncomitancies

H50.10

Unspecified exotropia

H50.111 – H50.112

Monocular exotropia

H50.121 – H50.122

Monocular exotropia with A pattern

H50.131 – H50.132

Monocular exotropia with V pattern

H50.141 – H50.142

Monocular exotropia with other noncomitancies

H50.15

Alternating exotropia

H50.16

Alternating exotropia with A pattern

H50.17

Alternating exotropia with V pattern

H50.18

Alternating exotropia with other noncomitancies

H50.21 – H50.22

Vertical strabismus

H50.30

Unspecified intermittent heterotropia

H50.311 – H50.312

Intermittent monocular esotropia

H50.32

Intermittent alternating esotropia

H50.331 – H50.332

Intermittent monocular exotropia

H50.34

Intermittent alternating exotropia

H50.40

Unspecified heterotropia

H50.411 – H50.412

Cyclotropia

H50.42

Monofixation syndrome

H50.43

Accommodative component in esotropia

H50.50

Unspecified heterophoria

H50.51

Esophoria

H50.52

Exophoria

H50.53

Vertical heterophoria

H50.54

Cyclophoria

H50.55

Alternating heterophoria

H50.60

Mechanical strabismus unspecified

H50.611 – H50.612

Brown's sheath syndrome

H50.69

Other mechanical strabismus

H50.811 – H50.812

Duane's syndrome

H50.89

Other specified strabismus

H50.9

Unspecified strabismus

H51.0

Palsy (spasm) of conjugate gaze

H51.11 – H51.12

Convergence insufficiency and excess

H51.20 – H51.23

Internuclear ophthalmoplegia

H51.8

Other specified disorders of binocular movement

I69.031 – I69.039

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage

I69.041 – I69.049

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage

I69.051 – I69.059

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage

I69.061 – I69.069

Other paralytic syndrome following nontraumatic subarachnoid hemorrhage

I69.131 – I69.139

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage

I69.141 – I69.149

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage

I69.151 – I69.159

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage

I69.161 – I69.169

Other paralytic syndrome following nontraumatic intracerebral hemorrhage

I69.231 – I69.239

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage

I69.241 – I69.249

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage

I69.251 – I69.259

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage

I69.261 – I69.269

Other paralytic syndrome following other nontraumatic intracranial hemorrhage

I69.331 – I69.339

Monoplegia of upper limb following cerebral infarction

I69.341 – I69.349

Monoplegia of lower limb following cerebral infarction

I69.351 – I69.359

Hemiplegia and hemiparesis following cerebral infarction

I69.361 – I69.369

Other paralytic syndrome following cerebral infarction

I69.831 – I69.839

Monoplegia of upper limb following other cerebrovascular disease

I69.841 – I69.849

Monoplegia of lower limb following other cerebrovascular disease

I69.851 – I69.859

Hemiplegia and hemiparesis following other cerebrovascular disease

I69.861 – I69.869

Hemiplegia and hemiparesis following other cerebrovascular disease

I69.931 – I69.939

Monoplegia of upper limb following unspecified cerebrovascular disease

I69.941 – I69.949

Monoplegia of lower limb following unspecified cerebrovascular disease

I69.951 – I69.959

Hemiplegia and hemiparesis following unspecified cerebrovascular disease

I69.961 – I69.969

Other paralytic syndrome following unspecified cerebrovascular disease

J38.5

Laryngeal spasm

K11.7

Disturbance of salivary secretion

K22.0

Achalasia of cardia

K22.5

Diverticulum of esophagus, acquired

K44.9

Diaphragmatic hernia without obstruction or gangrene

K60.2

Anal fissure, unspecified

L74.510

Primary focal hyperhidrosis, axilla

L74.511

Primary focal hyperhidrosis, face

L74.512

Primary focal hyperhidrosis, palms

L74.513

Primary focal hyperhidrosis, soles

L74.519

Primary focal hyperhidrosis, unspecified

L74.52

Secondary focal hyperhidrosis

M43.6

Torticollis

M62.40

Contracture of muscle, unspecified site

M62.838

Other muscle spasm

N31.8

Other neuromuscular dysfunction of bladder

N31.9

Neuromuscular dysfunction of bladder, unspecified

N32.81

Overactive bladder

N36.44

Muscular disorders of urethra

N39.41

Urge incontinence

N39.46

Mixed incontinence

N39.492

Postural (urinary) incontinence

Q43.1

Hirschsprung's disease

R35.0

Frequency of micturition

R49.0

Dysphonia

R49.8

Other voice and resonance disorders

R68.2

Dry mouth, unspecified

S04.9XXS

Injury of unspecified cranial nerve, sequel

S06.9X9S

Unspecified intracranial injury with loss of consciousness of unspecified duration, sequel

S14.109S

Unspecified injury at unspecified level of cervical spinal cord, sequel

S14.2XXS

Injury of nerve root of cervical spine, sequela

S14.9XXS

Injury of unspecified nerves of neck, sequel

S24.109S

Unspecified injury at unspecified level of thoracic spinal cord, sequela

S24.2XXS

Injury of nerve root of thoracic spine, sequel

S24.9XXS

Injury of unspecified nerve of thorax, sequel

S34.109S

Unspecified injury to unspecified level of lumbar spinal cord, sequela

S34.139S

Unspecified injury to sacral spinal cord, sequela

S34.21XS

Injury of nerve root of lumbar spine, sequel

S34.22XS

Injury of nerve root of sacral spine, sequel

S34.9XXS

Injury of unspecified nerves at abdomen, lower back and pelvis level, sequela

ICD-10 Diagnoses Codes That Support Medical Necessity of Dysport (J0586):

G11.4

Hereditary spastic paraplegia

G24.3

Spasmodic torticollis

G25.89

Other specified extrapyramidal and movement disorders

G35

Multiple sclerosis

G36.0

Neuromyelitis optica

G37.0

Diffuse sclerosis of central nervous system

G37.1

Central demyelination of corpus callosum

G37.2

Central pontine myelinolysis

G37.3

Acute transverse myelitis in demyelinating disease of central nervous system

G37.5

Concentric sclerosis [Balo] of central nervous system

G37.8

Other specified demyelinating diseases of central nervous system

G37.9

Demyelinating disease of central nervous system, unspecified

G80.0 – G80.9

Cerebral palsy

G81.10 – G81.14

Spastic hemiplegia

G82.20 – G82.22

Paraplegia

G82.50 – G82.54

Quadriplegia

G83.0

Diplegia of upper limbs

G83.20 – G83.24

Monoplegia of upper limb

G83.4

Cauda equina syndrome

G83.81

Brown-Sequard syndrome

G83.82

Anterior cord syndrome

G83.89

Other specified paralytic syndromes

I69.031 – I69.039

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage

I69.041 – I69.049

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage

I69.051 – I69.059

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage

I69.061 – I69.069

Other paralytic syndrome following nontraumatic subarachnoid hemorrhage

I69.131 – I69.139

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage

I69.141 – I69.149

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage

I69.151 – I69.159

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage

I69.161 – I69.169

Other paralytic syndrome following nontraumatic intracerebral hemorrhage

I69.231 – I69.239

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage

I69.241 – I69.249

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage

I69.251 – I69.259

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage

I69.261 – I69.269

Other paralytic syndrome following other nontraumatic intracranial hemorrhage

I69.331 – I69.339

Monoplegia of upper limb following cerebral infarction

I69.341 – I69.349

Monoplegia of lower limb following cerebral infarction

I69.351 – I69.359

Hemiplegia and hemiparesis following cerebral infarction

I69.361 – I69.369

Other paralytic syndrome following cerebral infarction

I69.831 – I69.839

Monoplegia of upper limb following other cerebrovascular disease

I69.841 – I69.849

Monoplegia of lower limb following other cerebrovascular disease

I69.851 – I69.859

Hemiplegia and hemiparesis following other cerebrovascular disease

I69.861 – I69.869

Hemiplegia and hemiparesis following other cerebrovascular disease

I69.931 – I69.939

Monoplegia of upper limb following unspecified cerebrovascular disease

I69.941 – I69.949

Monoplegia of lower limb following unspecified cerebrovascular disease

I69.951 – I69.959

Hemiplegia and hemiparesis following unspecified cerebrovascular disease

I69.961 – I69.969

Other paralytic syndrome following unspecified cerebrovascular disease

M43.6

Torticollis

S14.109S

Unspecified injury at unspecified level of cervical spinal cord, sequel

S14.2XXS

Injury of nerve root of cervical spine, sequela

S14.9XXS

Injury of unspecified nerves of neck, sequel

S24.109S

Unspecified injury at unspecified level of thoracic spinal cord, sequela

S24.2XXS

Injury of nerve root of thoracic spine, sequel

S24.9XXS

Injury of unspecified nerve of thorax, sequel

S34.109S

Unspecified injury to unspecified level of lumbar spinal cord, sequela

S34.139S

Unspecified injury to sacral spinal cord, sequela

S34.21XS

Injury of nerve root of lumbar spine, sequel

S34.22XS

Injury of nerve root of sacral spine, sequel

S34.9XXS

Injury of unspecified nerves at abdomen, lower back and pelvis level, sequela

ICD-10 Diagnoses Codes That Support Medical Necessity of Myobloc (J0587):

G24.3

Spasmodic torticollis

K11.7

Disturbance of salivary secretion

M43.6

Torticollis

R68.2

Dry mouth, unspecified

REIMBURSEMENT INFORMATION:

Injection of the vocal cords is done as an integral part of laryngoscopic guidance (31513, 31570, 31571), therefore does not warrant separate billing of the laryngoscope and injection.

Injection for treatment of achalasia requires a separate endoscopy procedure, which is billed and reimbursed separately.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

No National Coverage Determination (NCD) was found at the time of the last guideline reviewed date.

The following Local Coverage Determination (LCD) located at www.fcso.com was reviewed on the last guideline reviewed date:

• Botulinum toxins, (L29088)

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Abductor: any muscle that moves one part of the body away from another or away from the middle of the body.

Achalasia: idiopathic motility disorder of the esophagus characterized by a lack of peristalsis in the esophageal body and absent or incomplete relaxation of the lower esophageal sphincter (LES). There is no curative therapy for achalasia and both surgical (e.g., myotomy, pneumatic dilation) and nonsurgical palliative treatment modalities (e.g., botulinum toxin) have been developed with the aim of decreasing the LES pressure, thus facilitating esophageal emptying.

Anal fissure: tear in the anus

Axillary: armpit area

Blepharoplasty: any operation for the correction of a defect in the eyelids.

Blepharospasm: a twitching or spasmodic contraction of the orbicularis oculi muscle due to habit spasm, eyestrain, or nervous irritability.

Diverticulum: small pouch in the colon

Dyskinesia: involuntary movement

Dysphonia: any disorder with speech affecting voice quality or ability to produce voice.

Dystonia: a more general term describing a state of abnormal or disordered tonicity of muscle. Achalasia is an example of dystonia of the lower esophageal sphincter; cervical dystonia is also known as torticollis.

Esotropia: one or both eyes turning inward

Frey’s Syndrome (gustatory sweating): redness and sweating on the cheek area adjacent to the ear.

Hiatal hernia: the protrusion of the upper part of the stomach into the thorax through a tear or weakness in the diaphragm.

Hyperhidrosis: excessive sweating.

Oromandibular dystonia: characterized by continuous, bilateral, asynchronous muscle spasms in the face, jaw, pharynx, and tongue causing difficulty in jaw closing or opening and interfering with fluid and food intake and speech; muscles of the neck, larynx, and respiratory system may be involved in severe cases.

Palmar: relating to the palm of the hand

Myotomy: surgical procedure in which muscle is cut. A common example of a myotomy is the Heller myotomy in which muscles of the cardia (lower esophageal sphincter or LES) are cut, allowing for food and liquids to pass to the stomach. It is used to treat achalasia.

Neuromyelitis optica: an inflammatory demyelinating disorder of the CNS in which the immune system attacks the optic nerves and spinal cord.

Pneumatic dilation: type of esophageal dilation in which a balloon is inserted in the deflated form into the area of narrowing. It is then inflated with air to a certain pressure that is pre-set for a given circumference.

Schilder’s disease: a subacute or chronic form of leucoencephalopathy of children and adolescents.

Spasm: a sudden involuntary contraction of one or more muscle groups; includes cramps and contractures.

Spasticity: a disorder of muscle tone that occurs as the result of a variety of injuries to the central nervous system; characterized by a velocity-dependent increase in tonic-stretch reflexes with exaggerated tendon jerks.

Sternocleidomastoid: pertaining to the sternum, clavicle and mastoid process.

Strabismus: a visual disorder in which one eye cannot align with the other.

Torticollis: congenital or acquired stiff neck caused by spasmodic contraction of the neck muscles, drawing the head to one side with the chin pointing to the other side.

RELATED GUIDELINES:

Treatment of Hyperhidrosis, 01-94010-08

OTHER:

Migraine without aura diagnostic criteria

A. At least five attacks1 fulfilling criteria B to D

B. Headache attacks lasting 4 to 72 hours (untreated or unsuccessfully treated)

C. Headache has at least two of the following four characteristics:

1. Unilateral location

2. Pulsating quality

3. Moderate or severe pain intensity

4. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)

D. During headache at least one of the following:

1. Nausea and/or vomiting

2. Photophobia and phonophobia

E. Not better accounted for by another ICHD-3 diagnosis.

Migraine with aura diagnostic criteria

A. At least two attacks fulfilling criteria B and C

B. One or more of the following fully reversible aura symptoms:

1. Visual

2. Sensory

3. Speech and/or language

4. Motor

5. Brainstem

6. Retinal

C. At least two of the following four characteristics:

1. At least one aura symptom spreads gradually over ≥5 minutes, and/or two or more symptoms occur in succession

2. Each individual aura symptom lasts 5 to 60 minutes

3. At least one aura symptom is unilateral

4. The aura is accompanied, or followed within 60minutes, by headache

D. Not better accounted for by another ICHD-3 diagnosis, and transient ischemic attack has been excluded.

Chronic Migraine diagnostic criteria

A. Headache (tension-type-like and/or migraine-like) on ≥15 days per month for >3 months and fulfilling criteria B and C

B. Occurring in a patient who has had at least five attacks fulfilling criteria B to D for Migraine without

1. Aura and/or criteria B and C for Migraine with aura

C. On ≥8 days per month for >3 months, fulfilling any of the following:

1. Criteria C and D for Migraine without aura

2. Criteria B and C for Migraine with aura

3. Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative

D. Not better accounted for by another ICHD-3 diagnosis.

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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/11/17.

GUIDELINE UPDATE INFORMATION:

10/15/99

Medical Coverage Guideline Reformatted.

01/01/01

Coding changes.

07/15/01

Revised.

01/01/02

Coding changes.

01/01/03

HCPCS coding update.

03/15/03

Moved Botox information from section entitled “Other” to “When Services are Covered”.

12/15/03

Reviewed, revised to include criteria for covered indications; covered and non-covered indications expanded.

01/01/05

Added new primary axillary hyperhidrosis FDA indication, changed title, updated to new format.

08/15/05

Revised and Updated: added description, updated when services are covered, dosage/administration, precautions, CPT coding, ICD-9 diagnoses codes that support medical necessity, and references.

01/01/06

CPT code update. Revised codes: 31571, 64613, deleted expired code 90782.

02/15/06

Updated CPT coding: added 64614 chemo denervation of muscle(s), extremity (s), and/or trunk muscle (s) (e.g., for dystonia, cerebral palsy, multiple sclerosis).

05/15/06

Changed descriptor of CPT-4 code 92265 and added CPT-4 code 90772.

10/15/06

Revision consisting of adding CPT code 46505.

11/15/06

Removed ICD-9 codes until reviewed in January 2007.

01/01/07

MCG revised to include Medicare Part D as a program exception.

02/15/07

Annual Review; added indication for incontinence due to detrusor overactivity caused by spinal cord injury inadequately controlled by anticholinergic therapy. Reformatted and updated references.

04/15/07

Revision; consisting of adding CPT-4 codes 95872, 95873 & 95874 to range of codes.

06/15/07

Reformatted guideline.

11/15/07

Review and revision; consisting of rewriting the “Description” section, rewriting the “Dosage and Administration” section, removed Medicare Advantage from “Program Exceptions”, and updated references.

01/01/09

Annual HCPCS coding update: deleted code 90772; added code 96372.

05/15/09

Review and revision; consisting of removing diagnosis of Equines foot, Infantile Cerebral Palsy, Neuromyelitis optica and spasticity with pain and adding drooling associated with Parkinson disease, reformatted guideline and updated references.

10/15/09

Revision; consisting of adding new drug, Dysport™, changing name of MCG, revising description, adding Precautions section and updating references.

01/01/10

Annual HCPCS coding update: added HCPCS code J0586 and revised descriptor for codes 95870, J0585, and J0587.

02/15/10

Review and revision; consisting of adding palmar hyperhidrosis as a covered indication and updating references.

11/15/10

Revision; consisting of adding description of new botulinum toxin and including in the position statement.

02/15/11

Review and revision; consisting of adding updating position statement coding and references.

04/01/11

Revision; consisting of updating codes.

08/05/11

Revision: changes to language around Certificate of Medical Necessity; grammatical changes.

01/01/12

Revision to guideline; consisting of updating codes.

02/15/11

Review and revision to guideline; consisting of updating position statement, precautions, coding and references.

11/15/12

Revision to guideline; consisting of clarifying blepharospasm and hyperhidrosis criteria.

02/15/13

Review and revision to guideline; consisting of reformatting and revising position statement to expand coverage to allow for treatment of essential tremor and gustatory sweating; revised description, dosage/administration, and precautions sections; updated references; added pertinent definitions.

03/15/13

Review and revision to guideline; consisting of revising position statement to include coverage of idiopathic overactive bladder and updating references.

05/15/13

Review and revision to guideline; consisting of adding quantity limit and approval duration.

01/15/14

Revision to guideline; consisting of adding continuation criteria.

02/15/14

Review and revision to guideline; consisting of updating the position statement and references.

09/15/14

Revision to guideline; consisting of revising position statement and updating references.

02/15/15

Review and revision to guideline, consisting of updating references

05/15/15

Revision; updated billing/coding

06/15/15

Revision to guideline, consisting of updating position statement and references.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision to guidelines, consisting of updating position statement based on a new FDA-approved indication for Dysport.

01/15/16

Revision to guidelines consisting of updating the position statement.

02/15/16

Revision to guidelines consisting of updating the position statement and references.

05/15/16

Revision to guidelines consisting of clarifying dosage limits in position statement, new FDA-approved indication for Botox, and revision of ICD-10 codes.

10/01/16

Revision: ICD-10 code updates and new FDA-approved indication for Dysport.

12/15/16

Revision: The re-dosing interval was modified from 90 days to 12 weeks with a corresponding authorization duration of 24 weeks

02/15/17

Review and revision to guideline consisting of updating the position statement and references.

07/15/17

Revision to guideline consisting of clarifying the position statement and updating the dosage/administration section.

11/15/17

Revision to guideline consisting of updating the position statement and dosage/administration section with a higher dosage limit for Dysport.

Date Printed: December 16, 2017: 09:04 PM