Notification

Botulinum Toxin Agents


Notification Issue Date: 09/18/2019

This version of the policy will become effective 12/16/2019.

The policy has been updated to communicate expanded indications and corresponding diagnosis codes for onabotulinumtoxinA, (Botox® and Botox Cosmetic® [Allergan]), prabotulinumtoxinA-xvfs (Jeuveau™ [Evolus]), rimabotulinumtoxinB (Myobloc® [Solstice Neurosciences, Inc]), abobotulinumtoxinA (Dysport® [Ipsen Biopharmaceuticals]), and incobotulinumtoxinA (Xeomin® [Merz Pharmaceuticals, Raleigh, NC]).

The following codes were ADDED for onabotulinumtoxinA

G25.0 Essential tremor
N30.10 Interstitial cystitis (chronic) without hematuria
N30.11 Interstitial cystitis (chronic) with hematuria

Dual diagnosis for spasticity of limbs has been added, M62.838 Other muscle spasm (added), I69.398 Other sequelae of cerebral infarction (policy language stroke) – added.

The following codes were REMOVED for onabotulinumtoxinA

G43.821 Menstrual migraine, not intractable, with status migrainosus
G43.829 Menstrual migraine, not intractable, without status migrainosus
G43.831 Menstrual migraine, intractable, with status migrainosus
G43.839 Menstrual migraine, intractable, without status migrainosus
G43.A0 Cyclical vomiting, not intractable
G43.C0 Periodic headache syndromes in child or adult, not intractable
G43.C1 Periodic headache syndromes in child or adult, intractable
G24.01 Drug induced subacute dyskinesia
G24.4 Idiopathic orofacial dystonia

___________________________________________________________

Note: On 10/09/2019 the following revisions were made to the Policy section:

  • Under MEDICALLY NECESSARY/BOTULINUM TOXIN A prescribing providers were expanded to include headache specialists and pain specialists in addition to neurologists
  • Under OTHER TREATMENT PARAMETERS/PEDIATRIC INDIVIDUALS Botox® Cosmetic was removed from the parenthetical description of onabotulinumtoxinA


Medical Policy Bulletin


Title:Botulinum Toxin Agents

Policy #:08.00.26v

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

BOTULINUM TOXIN A
OnabotulinumtoxinA (Botox®), AbobotulinumtoxinA (Dysport®), IncobotuninumtoxinA (Xeomin®)

OnabotulinumtoxinA (Botox®), abobotulinumtoxinA (Dysport®), and incobotuninumtoxinA (Xeomin®) are considered medically necessary and, therefore, covered for the following indications:
  • Achalasia and cardiospasm when at least one of the following criteria is met:
    • The individual has failed conventional therapy (e.g., sitting upright after eating, use of achalasia wedge for positioning, use of protein pump inhibitors or calcium channel blockers) or has a contraindication to such therapy.
    • The individual is at high risk of complications from pneumatic dilation or surgical myotomy.
    • The individual has failed prior myotomy or dilation.
    • The individual has prior dilation-induced esophageal perforation.
    • The individual has an epiphrenic diverticulum or hiatal hernia.
  • Blepharospasm in individuals 12 years of age and older
  • Cervical dystonia (spasmodic torticollis)
  • Chronic anal fissure with anal spasm (proctalgia fugax) with documentation that the individual has been unresponsive to one of the following:
    • Conservative treatments (e.g., sitz baths, topical anesthetics and steroids, topical glyceryl trinitrate [nitroglycerin])
    • Lateral sphincterotomy
  • Prevention of chronic migraine headache or probable migraine headache occurring at least 15 days per month for at least three months when the duration of untreated headache on average is at least four hours per day. Initial treatment for botulinum toxin A is medically necessary for two cycles (i.e., 24 weeks) when all of the following criteria are met:
    • A neurologist, headache specialist, or pain specialist has established a diagnosis of either of the following:
      • Chronic migraine headache OR
      • Chronic probable migraine headache when the individual has experienced either any two of the following pain criteria:
          • Moderate-to-severe headache pain intensity
          • Unilateral headache pain
            1. Pain aggravated by movement or pain that prohibits movement
            2. Throbbing headache pain
OR
          • One of the above pain criteria and one of the following associated symptoms:
            1. Nausea
            2. Sensitivity to light (photophobia) and sound (phonophobia)
AND
    • The individual has failed to respond to a four-week course each of at least two agents from any different classes of medications noted below (at a minimally effective or maximally tolerated dose), if not contraindicated:
      • Tricyclic antidepressants (TCAs), (e.g., amitriptyline [Elavil], nortriptyline [Pamelor])
      • Anticonvulsants (e.g., divalproex sodium [Depakote], valproic acid [Depakene], valproate sodium [Depakene, Depacon], topiramate [Topamax])
      • Beta-blockers (e.g., propranolol [Inderal], atenolol [Tenormin], metoprolol tartrate [Lopressor], nadolol [Corgard])
      • Calcitonin gene-related peptide receptor antagonist (e.g., [Aimovig®] erenumab-aooe, [Ajovy®] fremanezumab-vfrm, [Emgality®] galcanezumab-gnlm) for at least three months
    • The individual is not using (Botox®) onabotulinumtoxinA, (Dysport®) abobotulinumtoxinA, and (Xeomin®) incobotulinumtoxinA concurrently with a calcitonin gene-related peptide receptor antagonist (e.g., [Aimovig®] erenumab-aooe, [Ajovy®] fremanezumab-vfrm, [Emgality®] galcanezumab-gnlm)
  • Prevention of chronic migraine headache or probable migraine headache with continued treatment will be medically necessary every 12 weeks when all of the following criteria are met:
    • The provider reports a clinically significant decrease in frequency of headache days from the reported baseline of frequency prior to the initiation of the first series of botulinum toxin injections.
    • The re-treatment is based on continued, sustained improvement
  • Essential hand tremor in individuals, who failed treatment with oral agent(s) (e. g., propranolol [Inderal])
  • Focal dystonia or spastic dystonia: in order to relieve pain; to assist in posturing and walking; to increase range of motion; to assist in the outcome of physical therapy; and/or to reduce spasm, thus allowing adequate perineal hygiene after failure of conventional treatment methods, (e.g., trihexyphenidyl [Artane], tetrabenazine [Xenazine]) or if a contraindication to such treatments exist
  • Hemifacial spasm (HFS)
  • Interstitial cystitis, as a fourth line treatment option, after documented failure, intolerability, or contraindication to medical therapy (e.g., behavior/diet modification, pharmacologic therapy, pelvic floor physical therapy, intravesical instillations, hydrodistention)
  • Plantar - palmar hyperhidrosis refractory to conventional treatment options, including both topical and systemic pharmacotherapy (e.g., topical: astringents, iontophoresis; systemic: anticholinergic drugs; psychotherapy), unless clinically contraindicated AND one of the following:
    • The condition is significantly interfering with the ability to perform activities of daily living
    • The condition is causing persistent or chronic cutaneous complications, such as skin maceration, dermatitis, secondary fungal and microbial infections
  • Severe primary axillary hyperhidrosis in individuals, who manifest focal, visible, severe sweating beyond physiological needs for at least six months without apparent cause when at least two of the following criteria are met:
    • Age of onset is younger than 25 years of age
    • Focal sweating is bilateral and relatively symmetric
    • Focal sweating does not occur during sleep
    • Family history is positive for severe primary focal hyperhidrosis
    • Hyperhidrosis significantly impairs the individual's ability to participate in daily activities
  • Sialorrhea (excessive drooling) due to disabling conditions such as motor neuron disease or Parkinson's disease in individuals whose condition has failed to respond to a reasonable trial of traditional therapies (i.e., anticholinergics, speech therapy, surgical therapy) or who have a contraindication to such therapy
  • Spasmodic dysphonia/laryngeal dystonia (e.g., abductor dysphonia, adductor dysphonia)
  • Spasticity of limbs, related to any of the following:
    • Cerebral palsy, including use for treatment of equinus foot deformity
    • Demyelinating diseases of the central nervous system
    • Brain injury
    • Hemiplegia or paraplegia
    • Multiple sclerosis
    • Spinal cord injury
    • Stroke
  • Strabismus in visually mature individuals (12 years of age or older) who have vision in both eyes, are unable to maintain fusion of image, and have at least one of the following:
    • Diplopia
    • Abnormal head turn
    • Asthenopia
    • Impairment of peripheral vision due to esotropia
  • Urinary incontinence due to neurogenic bladder after documented failure, intolerability, or contraindication to medical therapy (e.g., pelvic floor exercises, diet/fluid management, anticholinergics, intermittent catheterization)
  • Urinary incontinence due to overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
    • The individual has a documented failure, intolerability, or contraindication to an anticholinergic medication. (e.g., darifenacin [Enablex], trospium [Trosec])

BOTULINUM TOXIN B
RimabotulinumtoxinB (Myobloc®)

RimabotulinumtoxinB (Myobloc® ) is considered medically necessary and, therefore, covered for the following indications:
  • Cervical dystonia (spasmodic torticollis)
  • Sialorrhea (excessive drooling) due to disabling conditions such as motor neuron disease or Parkinson's disease in individuals whose condition has failed to respond to a reasonable trial of traditional therapies (i.e., anticholinergics, speech therapy, surgical therapy) or who have a contraindication to such therapy

OTHER TREATMENT PARAMETERS

PEDIATRIC INDIVIDUALS
For pediatric individuals, onabotulinumtoxinA (Botox®) for spasticity of upper limbs and abobotulinumtoxinA (Dysport®) for spasticity of lower limbs in children aged 2 years and older are considered medically necessary and, therefore, covered.

The safety and effectiveness of rimabotulinumtoxinB (Myobloc®) and incobotulinumtoxinA (Xeomin®) have not been established in the pediatric population.

NOT MEDICALLY NECESSARY
Muscle spasm not associated with one of the conditions identified in this policy is considered not medically necessary and, therefore, not covered. Diagnosis codes representing not medically necessary diagnoses are not covered.

Continuation of treatment of larger muscle groups is considered not medically necessary if no response has been elicited with a maximum dose per site. Treatment may be resumed if deemed clinically appropriate. If two consecutive treatments of the appropriate dosage and type of botulinum toxin fail to produce a satisfactory clinical response, continuation of treatment is considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of onabotulinumtoxinA (Botox®), rimabotulinumtoxinB (Myobloc®), abobotulinumtoxinA (Dysport®), prabotulinumtoxinA-xvfs (Jeuveau™), and incobotulinumtoxinA (Xeomin®), including those listed below, are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics:
  • Bruxism
  • Constipation
  • Episodic migraine headache (i.e., 14 headache days or fewer per month)
  • Myofascial pain
  • Orofacial dyskinesia
  • Temporomandibular joint (TMJ) syndrome
  • Tension-type headache
  • Voiding dysfunction due to benign prostatic hyperplasia (BPH)

COSMETIC SERVICES

The use of onabotulinumtoxinA (Botox® and Botox® Cosmetic), rimabotulinumtoxinB (Myobloc®),abobotulinumtoxinA (Dysport®), prabotulinumtoxinA-xvfs (Jeuveau™), and incobotulinumtoxinA (Xeomin®)for the treatment of skin wrinkles (e.g., glabellar creases, smoker's lines, lipstick lines, crow's feet, laugh lines, wrinkled neck, aging neck) is considered cosmetic and is, therefore, a benefit contract exclusion.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

The generally accepted frequency for the treatment of spasticity or excessive muscular contractions is one botulinum toxin injection every three months.

Because the potency of each botulinum toxin agent is specific to its own method of preparation, units of biologic activity for each distinct preparation of botulinum toxin cannot be compared with or converted to units of other botulinum toxins.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, onabotulinumtoxinA (Botox®), rimabotulinumtoxinB (Myobloc®), incobotulinumtoxinA (Xeomin®), and abobotulinumtoxinA (Dysport®) are covered under the medical benefits of the Company’s products when the medical necessity criteria and dosing and frequency requirements listed in this medical policy are met.

Any services that are experimental/investigational or cosmetic are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

OnabotulinumtoxinA (Botox®) was initially approved by the US Food and Drug Administration (FDA) on December 9, 1991, for the treatment of blepharospasm and strabismus associated with dystonia. Supplemental approvals have since been issued by the FDA.

On April 15, 2002, Botox® A, marketed as Botox® Cosmetic (now also known as onabotulinumtoxinA) was approved; it is intended to improve the appearance of moderate-to-severe glabellar lines (e.g., frown lines, wrinkles). Supplemental approvals have since been issued by the FDA.

RimabotulinumtoxinB (Myobloc®) was approved by the FDA on December 8, 2000, for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and associated neck pain.

AbobotulinumtoxinA (Dysport®) was approved by the FDA on April 29, 2009, for the treatment of cervical dystonia in adults and the cosmetic use for the temporary improvement of glabellar lines associated with the procerus and corrugator muscle activity in adult patients younger than 65 years old. Supplemental approvals for abobotulinumtoxinA (Dysport®) have since been issued by the FDA.

IncobotulinumtoxinA (Xeomin®) was approved by the FDA on July 30, 2010, for treatment of adults with cervical dystonia (for both botulinum toxin--naive and previously treated individuals) and for treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox®). Supplemental approvals for incobotulinumtoxinA (Xeomin®) have since been issued by the FDA.

PrabotulinumtoxinA-xvfs (Jeuveau™) was approved by the FDA on February 1, 2019, for use in adults to temporarily improve the appearance of moderate to severe glabellar lines (wrinkles between the eyebrows) in adults.

Description

Botulinum toxins have traditionally been associated with foodborne diseases, but medically there has been much interest in the ability of the toxins to block neuromuscular conduction. Botulinum toxin is a neurotoxin derived from the organism Clostridium botulinum (C. botulinum). The seven distinct neurotoxins (A, B, C, D, E, F, G) produced from C. botulinum differ in their binding and pharmacologic activity, but they all exhibit a similar molecular structure and share primarily the same mechanism of action: the inhibition of acetylcholine release at the neuromuscular junction.

The blocking of neuromuscular conduction is believed to be a three-step process: (1) extracellular binding of the toxin with the presynaptic site of the neuromuscular junction; (2) internalization and release of the toxin into the cytosol of the nerve terminals; and (3) ultimate inhibition of acetylcholine release from the nerve terminals. The resulting decrease of contractility, strength, and tension of certain muscle groups may improve clinical outcomes in individuals who have diseases associated with inappropriate or exaggerated muscle contractions.

Currently, five US Food and Drug Administration (FDA)--approved botulinum toxin products are available in the United States:
  • OnabotulinumtoxinA (Allergan) (Botox® and Botox Cosmetic®)
  • PrabotulinumtoxinA-xvfs (Jeuveau™)
  • RimabotulinumtoxinB (Solstice Neurosciences, Inc) (Myobloc®)
  • AbobotulinumtoxinA (Ipsen Biopharmaceuticals) (Dysport®)
  • IncobotulinumtoxinA (Merz Pharmaceuticals, Raleigh, NC) (Xeomin®)

These products are distinct and are not interchangeable with other botulinum toxin agents; thus, the units of each product cannot be compared or converted into units of another botulinum toxin product.

The FDA-approved uses of these products are as follows:
  • Axillary hyperhidrosis, primary (severe underarm sweating):
    • OnabotulinumtoxinA (Botox®)
  • Blepharospasm (abnormal tics and twitches of the eyelids):
    • OnabotulinumtoxinA (Botox®) in those ages 12 years and older
    • IncobotulinumtoxinA (Xeomin®) in adults previously treated with onabotulinumtoxinA (Botox®)
  • Cervical dystonia (a condition that affects the muscles in the neck that control the position of the head):
    • OnabotulinumtoxinA (Botox®)
    • AbobotulinumtoxinA (Dysport®)
    • RimabotulinumtoxinB (Myobloc®)
    • IncobotulinumtoxinA (Xeomin®) (botulinum toxin--naive and previously treated individuals)
  • Forehead lines associated with frontalis muscle activity (to temporarily improve the appearance):
    • OnabotulinumtoxinA (Botox Cosmetic®)
  • Glabellar lines (to temporarily improve the appearance of frown lines between the eyebrows):
    • OnabotulinumtoxinA (Botox Cosmetic®)
    • AbobotulinumtoxinA (Dysport®)
    • PrabotulinumtoxinA-xvfs (Jeuveau™)
    • IncobotulinumtoxinA (Xeomin®)
  • Lateral canthal lines (crow's feet) associated with orbicularis oculi activity (to temporary improve the appearance):
    • OnabotulinumtoxinA (Botox Cosmetic®)
  • Migraine, chronic:
    • OnabotulinumtoxinA (Botox®)
  • Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency:
    • OnabotulinumtoxinA (Botox®)
  • Sialorrhea, chronic in adults:
    • IncobotulinumtoxinA (Xeomin®)
  • Spasticity of upper limb:
    • IncobotulinumtoxinA (Xeomin®)
  • Spasticity of lower limb:
    • OnabotulinumtoxinA (Botox®) in adults
    • AbobotulinumtoxinA (Dysport®) in children 2 years of age and older and adults
  • Spasticity of upper limb in adults:
    • OnabotulinumtoxinA (Botox®)
    • AbobotulinumtoxinA (Dysport®) in adults
    • IncobotulinumtoxinA (Xeomin®)
  • Strabismus (crossed eyes):
    • OnabotulinumtoxinA (Botox®) in those ages 12 years and older
  • Urinary incontinence due to neurogenic bladder:
    • OnabotulinumtoxinA (Botox®)

On October 15, 2010, the FDA approved onabotulinumtoxinA (Botox®) for prophylaxis of headaches in adults with chronic migraine headache (at least 15 days per month with headache lasting at least 4 hours per day). The approval for chronic migraine was based on results of the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) program, which consisted of 2 double-blind, placebo-controlled clinical trials that included 1384 adults from 122 centers in North America and Europe. In both of these studies, patients receiving onabotulinumtoxinA (Botox®) had a significantly greater decrease in the frequency of headache days from baseline compared with placebo at 24 weeks: 7.8 and 9.2 fewer days for the treated groups vs. 6.4 and 6.9 days for the placebo groups, respectively. Treated patients also had a total cumulative reduction in headache hours by 107 and 134 hours, respectively, compared with 70 and 95 hours for the placebo groups.

OnabotulinumtoxinA (Botox® and Botox® Cosmetic) block neuromuscular transmission by cleaving synaptosomal-associated protein (SNAP)-25, a protein responsible for the release of acetylcholine from nerve endings. This, in turn, produces a decrease in chemical muscle denervation, resulting in reduced muscular contractions. Similarly, rimabotulinumtoxinB (Myobloc®) and abobotulinumtoxinA (Dysport®) use a mechanism of like action to inhibit the release of cetylcholine.

On December 8, 2000 FDA approved rimabotulinumtoxinB (Myobloc®) for the treatment of cervical dystonia. The approval for cervical dystonia was based on two phase three, randomized, multi-center, double-blind, placebo-controlled studies. Both studies enrolled only adult patients who had a history of receiving botulinum toxin type A. Study #301 enrolled patients who were perceived as having an acceptable response to type A toxin, while Study #302 enrolled only patients who had secondarily lost responsiveness to type A toxin. Study #301 enrolled 109 individuals, and 77 individuals were enrolled into Study #302. Patient evaluations continued for 16 weeks post injection. The primary efficacy outcome variable for both studies was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score (scale range of possible scores is 0–87) at Week 4. The secondary endpoints were the Patient Global and Physician Global Assessments of change at Week 4. TWSTRS Total Score at Week 4 and Patient Global Assessment among subgroups by gender or age showed consistent treatment-associated effects across these subgroups.

RimabotulinumtoxinB (Myobloc®) is a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium Clostridium botulinum type B (Bean strain) and exists in noncovalent association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin complex.

RimabotulinumtoxinB (Myobloc®) is a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium Clostridium botulinum type B (Bean strain) and exists in noncovalent association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin complex.

On April 29, 2009, abobotulinumtoxinA (Dysport®) was approved by the FDA for the treatment of cervical dystonia. AbobotulinumtoxinA (Dysport®) was evaluated in two randomized, double blind, placebo controlled, single dose, parallel group studies in treatment-naïve cervical dystonia patients. 252 patients were enrolled. The primary assessment of efficacy was based on the total Toronto Western Spasmodic. Torticolls Rating Scale (TWSTRS) change from baseline at Week 4 for both studies. The scale evaluates the severity of dystonia, patient perceived disability from dystonia, and pain. The adjusted mean change from baseline in the TWSTRS total score was statistically significantly greater for the abobotulinumtoxinA (Dysport®) group than the placebo group at Weeks 4 in both studies.

AbobotulinumtoxinA (Dysport®) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.

The FDA has issued an import alert which states that "only botulinum toxin manufactured under US license and bearing the US license number on its labeling may be imported into the United States unless the unlicensed version has an Investigational New Drug (IND) application accepted by the Center for Drug Evaluation and Research."

COSMETIC SERVICES

Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issues by leading professional organizations and government entities.
References


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Acquadro MA, Borodic GE. Botulinum toxin efficacy for the treatment of pain. J Clin Anesth. 2005;17(5):328-330.

Adler CH, Bansberg SF, Krein-Jones K, Hentz JG. Safety and efficacy of botulinum toxin type B (Myobloc) in adductor spasmodic dysphonia. Mov Disord. 2004;19(9):1075-1079.

Allergan, Inc., Irvine, California. OnabotulinumtoxinA (Botox®) Product Information. [Allergan Web site]. Updated 09/2018. Available at: http://www.botox.com/. And https://www.botoxspasticity.com/about-spasticity/causesAccessed March 11, 2019.

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Batisti JP, Kleinfelder AD, Galli NB, et al. Treatment of hemifacial spasm with botulinum toxin type a: effective long lasting and well tolerated. Arq Neuropsiquiatr. 2017;75:87-91.

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Choe WJ, Kim J. Increasing the area and varying the dosage of botulinum toxin a injections for effective treatment of hemifacial spasm. Acta Otolaryngol. 2016;136:952-955.

Costa J, Espirito-Santo C, Borges A, et al. Botulimum toxin type A therapy for hemifacial spasm. Cochrane Database Syst Rev. 2005 Jan 25; (1):CD004899.

Costa J, Espírito-Santo CC, Borges AA, et al., Botulinum Toxin type A (BtA) muscular injections are beneficial in treating hemifacial spasm. Cochrane. [Internet]. 01/24/2005.

Dashtipour K, Chen JJ, Frei K, et al., Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Blepharospasm and Hemifacial Spasm. [NCPI Web site]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636029/.

De Andres J, Cerda-Olmedo G, Valia JC, et al. Use of botulinum toxin in the treatment of chronic myofascial pain. Clin J Pain. 2003;19(4):269-275.

Defazio G, Abbruzzese G, Girlanda P, et al. Botulinum toxin A treatment for primary hemifacial spasm: a 10-year multicenter study. Arch Neurol. 2002 Mar;59(3):418-20.

Diamond S. A fresh look at migraine therapy. New treatments promise improved management. Postgrad Med. 2001;109(1):49-60.

Diener HC, Dodick DW, Aurora SK, et al. PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia.2010;30(7):804-814.

Difazio M, Jabbari B. A focused review of the use of botulinum toxins for low back pain. Clin J Pain. 2002;18(6 Suppl):S155-S162.

Dodick DW, Turkel CC, DeGryse RE, et al; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: Pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache.2010;50(6):921-36.

Dodick DW, Turkel CC, DeGryse RE, et al. OnabotulinumtoxinA for treatment of chronic migraine: Pooled results form the double-blind, randomized, placebo-controlled phases of the PREEEMPT clinical program. Headache. 2010;50:221-236.

Dressler D, Adib Saberi F, Benecke R. Botulinum toxin type B for treatment of axillar hyperhidrosis. J Neurol. 2002;249(12):1729-1732.

(Dysport®) abobotulinumtoxinA [prescribing information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals. 09/2017. Available at: https://www.dysport.com/. Accessed May 22, 2019.

Egevad G, Petkova VY, Vilholm OJ. Sialorrhea in patients with Parkinson's disease: safety and administration of botulinum neurotoxin. J Parkinsons Dis. 2014;4(3):321-6. doi: 10.3233/JPD-140379.

Elkind AH, O'Carroll P, Blumenfeld A, et al. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7(10):688-696.

Ellies M, Gottstein U, Rohrbach-Volland S, Arglebe C, Laskawi R. Reduction of salivary flow with botulinum toxin: extended report on 33 patients with drooling, salivary fistulas, and sialadenitis. Laryngoscope. 2004 Oct;114(10):1856-60.
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Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005;103(2):377-383.

Ferrari AP Jr, Siqueira ES, Brant CQ. Treatment of achalasia in Chagas’ disease with botulinum toxin. N Engl J Med. 1995;332(12):824-825.

Fried GW, Fried KM. Spinal cord injury and use of botulinum toxin in reducing spasticity. Phys Med Rehabil Clin N Am. 2003;14(4):901-910.

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Naumann M, So Y, Argoff CE, et al. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment:Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1707-1714.

Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson’s disease. Neurology.2004;62(1):37-40.

Osako M, Keltner JL. Botulinum A toxin (Oculinum®) in ophthalmology. Surv Ophthalmol. 1991;36(1):28-46.

Pasricha PJ, Miskovsky EP, Kalloo AN. Intrasphincteric injection of botulinum toxin for suspected sphincter of Oddi dysfunction. Gut. 1994;35(9):1319-1321.

Porta M, Gamba M, Bertacchi G, Vaj P. Treatment of sialorrhea with ultrasound guided botulinum toxin type A injection in patients with neurological disorders. J Neurol Neurosurg Psychiatry. 2001;70:538-540.

Prajapati DN, Hogan WJ. Sphincter of Oddi dysfunction and other functional biliary disorders: evaluation and treatment. Gastroenterol Clin N Am. 2003;32(2):601-618.

Racette BA, Good L, Sagitto S, Perlmutter JS. Botulinum toxin B reduces sialorrhea in parkinsonism. Mov Disord. 2003;18(9):1059-1061.

Raj PP. Botulinum toxin therapy in pain management. Anesthesiol Clin North America. 2003;21(4):715-731.

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Rollnik JD, Tanneberger O, Schubert M, et al. Treatment of tension-type headache with botulinum toxin type A: a double-blind, placebo-controlled study. Headache. 2000;40(4):300-305.

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Sataloff RT, Heman-Ackah YD, Simpson LL, et al. Botulinum toxin type B for treatment of spasmodic dysphonia: a case report. J Voice. 2002;16(3):422-424.

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Schmitt WJ, Slowey E, Fravi N, et al. Effect of botulinum toxin A injections in the treatment of chronic tension-type headache: a double-blind, placebo-controlled trial. Headache. 2001;41(7):658-664.

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Silberstein SD, Stark SR, Lucas SM, et al. BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005;80(9):1126-1137.

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Simpson DM, Gracies JM, Yablon SA, Barbano R, Brashear A, BoNT/TZD Study Team. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry. 2009;80(4):380-385.

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Smith HS, Audette J, Royal MA. Botulinum toxin in pain management of soft tissue syndromes. Clin J Pain. 2002;18(6 Suppl):S147-S154.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

THE FOLLOWING CODE REPRESENTS ONABOTULINUMTOXINA (BOTOX®)

J0585 Injection, onabotulinumtoxina, 1 unit

THE FOLLOWING CODE REPRESENTS ABOBOTULINUMTOXINA (DYSPORT®)

J0586 Injection, abobotulinumtoxinA, 5 units

THE FOLLOWING CODE REPRESENTS RIMABOTULINUMTOXINB (MYOBLOC®)

J0587 Injection, rimabotulinumtoxinb, 100 units

THE FOLLOWING CODE REPRESENTS INCOBOTULINUMTOXINA (XEOMIN®)

J0588 Injection, incobotulinumtoxina, 1 unit


BENEFIT CONTRACT EXCLUSION

THE FOLLOWING CODES REPRESENT PRABOTULINUMTOXINA (JEUVEAU™)

C9399 Unclassified drugs or biologicals

J3590 Unclassified biologics



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Botulinum Toxin Agents
Description: ICD-10 Diagnosis Codes




Policy History

Revisions to 08.00.26v
12/16/2019The policy has been updated to communicate expanded indications and corresponding diagnosis codes for onabotulinumtoxinA, (Botox® and Botox Cosmetic® [Allergan]), prabotulinumtoxinA-xvfs (Jeuveau™ [Evolus]), rimabotulinumtoxinB (Myobloc® [Solstice Neurosciences, Inc]), abobotulinumtoxinA (Dysport® [Ipsen Biopharmaceuticals]), and incobotulinumtoxinA (Xeomin® [Merz Pharmaceuticals, Raleigh, NC]).

The following codes were ADDED for onabotulinumtoxinA
G25.0 Essential tremor
N30.10 Interstitial cystitis (chronic) without hematuria
N30.11 Interstitial cystitis (chronic) with hematuria

Dual diagnosis for spasticity of limbs has been added, M62.838 Other muscle spasm (added), I69.398 Other sequelae of cerebral infarction (policy language stroke) – added.

The following codes were REMOVED for onabotulinumtoxinA
G43.821 Menstrual migraine, not intractable, with status migrainosus
G43.829 Menstrual migraine, not intractable, without status migrainosus
G43.831 Menstrual migraine, intractable, with status migrainosus
G43.839 Menstrual migraine, intractable, without status migrainosus
G43.A0 Cyclical vomiting, not intractable
G43.C0 Periodic headache syndromes in child or adult, not intractable
G43.C1 Periodic headache syndromes in child or adult, intractable
G24.01 Drug induced subacute dyskinesia
G24.4 Idiopathic orofacial dystonia

Revisions to 08.00.26u
01/28/2019The policy has been updated to communicate expanded indications and corresponding diagnosis codes for (Botox®) onabotulinumtoxinA, Myobloc® (rimabotulinumtoxinB), (Dysport®) abobotulinumtoxinA, and Xeomin® (incobotulinumtoxinA).

The following codes were removed for Botox since more appropriate codes are available:
K60.0 Acute anal fissure
K60.2 Anal fissure, unspecified
L74.52 Secondary focal hyperhidrosis
R25.0 Abnormal head movements
R25.8 Other abnormal involuntary movements
R25.9 Unspecified abnormal involuntary movements

The following codes were added for all 4 agents (Botox, Myobloc, Dysport, Xeomin) due to cosmetic use (benefit contract exclusion):
L57.2 Cutis rhomboidalis nuchae
L57.4 Cutis laxa senilis
L57.8 Other skin changes due to chronic exposure to nonionizing radiation

L98.8 Other specified disorders of the skin and subcutaneous tissue

The dosage and frequency requirements for (Botox®) onabotulinumtoxinA has been removed from the policy.

Revisions to 08.00.26t
10/01/2018This policy has been identified for the ICD-10 CM code update, effective 10/01/2018.

The following ICD-10 CM code has been termed from this policy:
G51.3 Clonic hemifacial spasm

The following ICD-10 CM codes have been added to this policy:
G51.31 Clonic hemifacial spasm, right
G51.32 Clonic hemifacial spasm, left
G51.33 Clonic hemifacial spasm, bilateral
G51.39 Clonic hemifacial spasm, unspecified


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 12/16/2019
Version Issued Date: 12/16/2019
Version Reissued Date: N/A

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