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:

Neuromuscular system

• Auriculotemporal syndrome in adult individuals to reduce severe symptoms including food-induced facial flushing and sweating or gustatory hyperhidrosis post-parotidectomy (e.g., Frey syndrome); or
• Blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older; or
• Cervical Dysonia (also known as spasmodic torticollis) in individuals 16 years of age or older; or
• Chronic migraine prevention in adult individuals 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 eight (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
  • Initial authorization will be for up to two (2) injection treatments for a six (6) month period.
• Epicondylitis (e.g., tennis elbow) in adult individuals who did not respond to conventional treatment; or
• Esotropia, congenital in pediatric individuals seven (7) months of age or younger; or
• Exotropia of third nerve palsy – Acute Injury to oculomotor nerve in adult individuals; or
• Focal spasticity in pediatric individuals two (2) to 17 years of age with cerebral palsy and concurrent equinus gait (tiptoeing); 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; or
• Idiopathic trigeminal neuralgia in adult individuals refractory to three (3) to six (6) months of treatment with antiepileptic medications; or
• Granuloma of the vocal cords in adult individuals refractory to conventional surgical and medical therapies; 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
• Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
  • Cerebral palsy, including use for treatment of equinus foot deformity; or
  • Demyelinating diseases of the central nervous system; or
  • Brain or spinal cord injury; or
  • Hemiplegia or paraplegia; or
  • Multiple sclerosis; or
  • Stroke; or
• Strabismus associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older; or
• Stuttering in adult individuals; or
• Temporomandibular joint disorder, chronic in adult individuals; or
• Tics and associated premonitory symptoms from Gilles de la Tourette’s syndrome in adult individuals; 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
• Voice tremor, essential (organic) in adult individuals; or
• Whiplash injury to neck in adult individuals with chronic whiplash-associated neck pain following a motor vehicle accident; and

Digestive System

• Anal fissure (chronic) in adult individuals for initial authorization of one (1) injection treatment for a three (3) month period; or
• Anismus related to pelvic floor dyssynergia in adult individuals who are refractory to biofeedback training, for a maximum of up to three (3) injection treatments for a three (3) month period; or
  
• Disorders of esophagus – dysphagia in adult individuals due to esophageal motility disorder or nonachalasia esophageal motility disorder; or
• Dysphagia in adult individuals due to cricopharyngeus muscle spasm or pure upper esophageal sphincter dysfunction; or
• Esophageal achalasia (failure in relaxation of the lower esophageal sphincter with swallowing and by a lack of esophageal peristalsis) in adult individuals who have not responded to dilation therapy or who are considered poor surgical candidates for initial authorization of one (1) injection for a three (3) month period;  or
• Sialorrhea (excessive salivation, drooling) when ALL of the following are met:
  • Pediatric individuals two (2) to 17 years of age with cerebral palsy; or
  • Individuals two (2) years of age or older who are neurologically impaired; or
  • Adult individuals with functional impairment originating from spasticity or dystonia resulting from Parkinson disease; and
  • Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or

Integumentary System

• Primary focal hyperhidrosis in adult individuals when ALL of the following criteria are met:
  • Diagnosis of severe hyperhidrosis in the axillary, palmar, plantar or craniofacial region; and
  • History of recurrent skin maceration with bacterial or fungal infections, (including but not limited to cutaneous disorders such as dermatophytosis (ringworm), pitted keratolysis, viral warts at the sites of hyperhidrosis); or
  • History of atopic dermatitis (atopic eczema) in spite of medical treatments with topical dermatological or systemic anticholinergic agents; and
  • Unresponsive to or unable to tolerate pharmacotherapy modalities prescribed for excessive sweating (including but not limited to anti-cholinergics, beta-blockers, or benzodiazepines); and
  • Topical 20% aluminum chloride or other extra strength antiperspirants are ineffective or result in a severe rash; and
  • Initial authorization will be for one (1) injection treatment per region for a three (3) month period; or

Urinary system

• Benign prostatic hyperplasia in adult individuals 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
• Neurogenic detrusor overactivity (NDO) in pediatric individuals five (5) years of age or older who have an inadequate response to or are intolerant of anticholinergic medication; 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 beta-3 adrenergic agonist; or
• Urinary incontinence due to detrusor overactivity due to neurologic condition (e.g., spinal cord injury, multiple sclerosis) adult individuals, who 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 beta-3 adrenergic agonist; o

Initial authorization for ALL criteria above will be for up to four (4) injection treatments per region in a 12-month period unless otherwise specified above.

Reauthorization Criteria

• For chronic migraine, continuation of therapy beyond six (6) months may be considered medically necessary when ALL of 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; and
  • Reauthorization will be for up to four (4) injections treatments for a 12-month period; or
• For hyperhidrosis, continuation of therapy beyond three (3) months may be considered medically necessary when ALL of the following criteria are met:
  • Documentation of an objective measurable effect indicating positive clinical response (i.e., improvement in hyperhidrosis severity scale); and
  • Reauthorization will be for up to four (4) injection treatments per region fora 12-month period; or
• For chronic anal fissure and achalasia, continuation of therapy beyond three (3) months may be considered medically necessary when ALL of the following criteria are met:
  • Documentation of positive clinical response; and
  • Reauthorization will be for one (1) injection treatment for a three (3) month period; or
• For ALL other indications listed above (excluding chronic migraine, hyperhidrosis, chronic anal fissure, and achalasia), continuation of therapy may be considered medically necessary when ALL of the following criteria are met:
  • Documentation of positive clinical response; and
  • Reauthorization will be for up to four (4) injection treatments per region in a 12-month period.

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

Injections performed more than four (4) times 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.

AbobotulinumtoxinA (Dysport) may be considered medically necessarywhen used in the treatment of ANY of the following conditions:

• Blepharospasm in adult individuals; or
• Cervical Dystonia (also known as spasmodic torticollis) in individuals 18 years of age or older; or
• Hemifacial spasms (7th cranial nerve palsy) in individuals 18 years of age or older; or
• Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
  • Cerebral palsy, including use for treatment of equinus foot deformity; or
  • Demyelinating diseases of the central nervous system; or
  • Brain or spinal cord injury; or
  • Hemiplegia or paraplegia; or
  • Multiple sclerosis; or
  • Stroke.

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

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

• Blepharospasm in adult individuals; or
• Cervical Dystonia (also known as spasmodic torticollis) in adult individuals; or
• Chronic sialorrhea in individuals two (2) years of age or older when ALL of the following are met:
  • Sialorrhea resulting from Parkinson’s disease, atypical parkinsonism, amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury; and
  • At least a three (3) month history of sialorrhea; and
  • Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
• Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
  • Cerebral palsy, including use for treatment of equinus foot deformity; or
  • Demyelinating diseases of the central nervous system; or
  • Brain or spinal cord injury; or
  • Hemiplegia or paraplegia; or
  • Multiple sclerosis; or
  • Stroke.

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

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

• Cervical Dystonia(also known as spasmodic torticollis) in adults; or
• Chronic sialorrhea in adult individuals when ALL of the following are met:
  • Sialorrhea resulting from Parkinson’s disease, atypical parkinsonism, ALS, stroke, or traumatic brain injury; and
  • At least a three (3) month history of sialorrhea; and
  • Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); 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 beta-3 adrenergic agonist.

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

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

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.