Chemodenervations (i.e., botulinum toxin injections) are intramuscular injections of neurotoxins. The toxin acts by blocking release of acetylcholine at the neuromuscular junction thus reducing the tone of overactive muscles. There are several commercial products (consisting of either serotype-A or serotype-B) currently available for use. Each differs in its unit potency, side effects, and duration of action. The clinical goals for utilizing neurotoxin injections are to result in a temporary chemodenervation of the effected muscle at the neuromuscular junction thus: reducing pain or increasing comfort, improving function, preventing or treating musculoskeletal complications, facilitating ease of care, and/or for improving the general appearance, mobility and/or phonation in patients presenting with spasticity or dystonia.

OnabotulinumtoxinA (Botox^®) may be considered medically necessary when used in the treatment of ANY of the following conditions:

• Blepharospasm  associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle; or
• Dystonia, cervical also known as spasmodic torticollis in individuals age 16 years of age or older to reduce the associated severity of abnormal head position and neck pain associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and 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); or
• Chronic migraine prevention in individuals 18 years of age or older for an initial six (6) month trial when ALL of the following criteria are met:
  • Prescribed by or in consultation with a neurologist or headache specialist; and
    
  • A healthcare provider trained in administration of onabotulinumtoxinA (Botox) is administering the drug; and
  • A diagnosis of chronic migraine headache defined as greater than or equal to 15 days per month for greater than three (3) months with features of migraine headache on at least 8 days per month lasting four hours a day or longer [e.g. has been established using the International Classification of Headache Disorders, Third Edition (ICHD-III)]; and
  • There is a persistent three (3) month history of recurring debilitating headaches as defined above and documented by a headache diary; and
  • The headaches are not caused by medication rebound (the individual is not taking narcotics or triptans exceeding more than 18 doses per month) or lifestyle issues (e.g., sleep patterns, caffeine use, etc.); and
  • Adequate trials of prophylactic therapy from at least two (2) different therapy classes (e.g., antiseizure, beta blockers, tricyclic antidepressants) were either not effective or not tolerated. Documentation of trials and failure should include that these medications have been prescribed at adequate doses and for a reasonable length of time (i.e., six (6) weeks each); and
• Chronic migraine continued treatment beyond six (6) months (up to four injection treatments in a 12-month period) may be considered medically necessary when ALL the following criteria are met:
  • Migraine headache frequency reduced by at least 50 percent from baseline; and
  • Migraine headache hours reduced at least 50 percent from baseline; or
• Urinary incontinence due to detrusor overactivity due to neurologic condition (e.g., spinal cord injury, multiple sclerosis), that have an inadequate response to or intolerant of conservative therapy (e.g., moderation of fluid intake, avoidance of alcohol, caffeine, and medications such as diuretics, control of chronic cough and constipation, smoking cessation, etc.) and medical therapy with an anticholinergic medication; or
• Spasticity lower limb in adult individuals to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor halluces longus, and flexor digitorum longus); or
• Spasticity, lower limb in individuals two (2) to 17 years of age, excluding spasticity caused by cerebral palsy; or
• Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adult individuals who have inadequate response to or intolerant of an anticholinergic medication or
• Strabismus associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals greater or equal to 12 years of age; or
• Spasticity, upper limb in individuals 18 years of age or older, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus); or
• Spasticity, upper limb in individual two (2) to 17 years of age.

All other uses of onabotulinumtoxinA (Botox) are not medically necessary.

Injections performed on a more frequent basis may be considered not medically necessary. In addition, more than four (4) injections per region per year may be considered not medically necessary.

The use of electrical muscle stimulation or needle electromyography may be considered medically necessary for guidance in conjunction with chemodenervation.

The use of chemodenervation is considered not medically necessary for cosmetic purposes as well as all other indications.

OnabotulinumtoxinA (Botox) and other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

OnabotulinumtoxinA (Botox) may be considered medically necessary for the following medically accepted non-FDA approved indications when used in the treatment of ANY of the following conditions:

• Anal fissure (chronic) in adult individuals; or
• Anismus related to pelvic floor dyssynergia in adult individuals who are refractory to biofeedback training, for a maximum of three (3) treatments during a three (3) month period; or
•  Auriculotemporal syndrome in adults to reduce severe symptoms including food-induced facial flushing and sweating or gustatory hyperhidrosis post-parotidectomy (e.g. Frey syndrome; or
• Benign prostatic hyperplasia in adults who no longer respond to medication and refuse surgical treatment with moderate to severe symptoms of urinary obstruction based on the American Urological Association (AUA) index, mean peak urinary flow rate less than 15 mL/sec with voided volume of at least 150 mL, and an enlarged prostate gland; or
• Cerebral palsy in individuals with upper and lower limb spasticity;  or
• Detrusor and sphincter dyssynergia in adults due to multiple sclerosis; or
• Voice failure after tracheoesophageal puncture and prosthesis placements after total laryngectomy in adult individuals (this is due to persistent focal constrictor hypertonicity/spasm); or
• Disorders of esophagus – dysphagia in adult individuals due to esophageal motility disorder or nonachalasia esophageal motility disorder (ie, diffuse ) months or younger;
• Dysphagia in adult individuals due to cricopharyngeus muscle spasm or pure upper esophageal sphincter dysfunction; or
• Esotropia, congenital in pediatric individuals age seven (7) months or younger; or
• Epicondylitis (e.g. tennis elbow) in adult individuals who did not respond to conventional treatment; or
• Epiphora, functional (e.g. excessive tear production) in adult individuals; or
• Esophageal achalasia (failure in relaxation of the lower esophageal sphincter with swallowing and by a lack of esophageal peristalsis) in individuals 18 years of age or older who have not responded to dilation therapy or who are considered poor surgical candidates; or
• Exotropia of third nerve palsy – Acute Injury to oculomotor nerve in adult individuals; or
• Focal spasticity in pediatric individuals age two (2) to 17 years of age with cerebral palsy and concurrent equinus gait (tiptoeing); or
• Granuloma of the vocal cords in adult individuals refractory to conventional surgical and medical therapies; or
• Hand tremors, severe in adult individuals due to Parkinson disease or essential tremor; or
• Headache, cervicogenic (whiplash headache) in adult individuals with chronic headache, unrelieved by other therapies, secondary to a cervical whiplash injury which restricts range of motion in the neck; or
• Hemifacial spasms (7th cranial nerve palsy) in adult individuals when failure of oral pharmacological therapies such as carbamazepine, baclofen and benzodiazepine; or
• Idiopathic trigeminal neuralgia in adult individuals refractory to three (3) to six (6) months of treatment with antiepileptic medications; or
• Laryngeal spasm (laryngeal dystonia or spasmodic dysphonia) in adult individuals; or
• Larynx closure as an adjunct to surgical treatment in adult individuals; or
• Myofascial pain syndrome in adult individuals with fibromyalgia; or
• Oro-facial-lingual-masticatory tardive dyskinesia due to dopamine blocking agents in adult individuals; or
• Oromandibular dystonia, Isolated in adult individuals refractory to optimal pharmacological therapy, surgery, or both; or
• Pharyngoesophageal segment spasm following total laryngectomy in adult individuals as an adjunct to voice therapy program; or
• Stuttering in adult individuals; or
• Sialorrhea (excessive salivation, drooling) in adult individuals with amyotrophic lateral sclerosis (ALS) or bulbar ALS; or
• Sialorrhea (excessive salivation, drooling) in pediatric (two (2) to 17 years of age) and adult individuals who are neurologically impaired; or
• Sialorrhea (excessive salivation, drooling) in pediatric individuals two (2) to 17 years of age with cerebral palsy; or
• Sialorrhea (drooling or excessive salivation) in adult individuals with functional impairment originating from spasticity or dystonia (conditions of involuntary sustained muscle contraction) resulting from Parkinson disease who have been refractory to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
• Temporomandibular joint disorder, chronic in adult individuals; or
• Thoracic outlet syndrome in adult individuals unresponsive to physical therapy and sub optimally managed with anesthetic and steroid injections; or
• Tics and associated premonitory symptoms from Gilles de la Tourette’s syndrome in adult individuals; or
• Whiplash injury to neck in adult individuals with chronic whiplash-associated neck pain following a motor vehicle accident; or
• Voice tremor, essential (organic) in adult individuals.

Note: Adult individual is defined as individuals 18 years of age or older.

All other uses of onabotulinumtoxinA (Botox) are considered not medically necessary.

AbobotulinumtoxinA (Dysport^™) may be considered medically necessary for the following FDA approved conditions:

• Dystonia, cervical (also known as spasmodic torticollis) in individuals 18 years of age or older; or
• Spasticity, upper and lower limb in individuals two (2) years of age or older.

All other uses of abobotulinumtoxinA (Dysport) are considered not medically necessary.

IncobotulinumtoxinA (Xeomin^®) may be considered medically necessary for individuals 18 years of age or older for the treatment of:

• Dystonia, cervical (also known as spasmodic torticollis) associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and 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), to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated individuals; or
• Blepharospasm characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle or facial nerve (VII) disorders including hemifacial spasm in individuals previously treated with onabotulinumtoxinA (Botox); or
• Sialorrhea, chronic due to Parkinson’s disease, atypical parkinsonism, stroke, or traumatic brain injury, with at least a three (3) month history of sialorrhea; or
• Spasticity, upper limb, to decrease the severity of increased muscle tone in elbow flexors, forearm pronators, wrist flexors, thumb, and finger flexors.

All other uses of incobotulinumtoxinA (Xeomin) are considered not medically necessary.

RimabotulinumtoxinB (Myobloc^®) may be considered medically necessary for adult individuals for the treatment of:

• Dystonia, cervical (also known as spasmodic torticollis) in individuals 18 years of age or older and 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); or
• Sialorrhea, chronic in individuals 18 years of age or older associated with Parkinson’s disease, ALS, stroke, and other causes with at least a three (3) month history of troublesome sialorrhea refractory to pharmacotherapy (including anticholinergics such as but not limited to scopolamine).

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.