Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Botulinum Toxin Agents

Policy #:08.00.26u

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

MEDICALLY NECESSARY

BOTOX® (ONABOTULINUMTOXINA), DYSPORT® (ABOBOTULINUMTOXINA), XEOMIN® (INCOBOTULINUMTOXINA)
Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), and Xeomin® (incobotulinumtoxinA) are considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Achalasia and cardiospasm when at least one of the following criteria are 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.
    • Prior myotomy or dilation has failed.
    • The individual has prior dilation-induced esophageal perforation.
    • The individual has an epiphrenic diverticulum or hiatal hernia.
  • Blepharospasm
  • Cervical dystonia (spasmodic torticollis): in order to decrease the severity of abnormal head position and resulting neck pain
  • Chronic anal fissure or anal spasm (proctalgia fugax) that has been unresponsive to conservative treatments (e.g., sitz baths, topical anesthetics and steroids, topical glyceryl trinitrate [nitroglycerin])
  • Chronic migraine headache: for the prevention of chronic migraine headache or probable migraine headache occurring at least 15 days per month for at least 3 months when the duration of untreated headache on average is at least 4 hours per day and when both of the following criteria are met:
    • A neurologist has established a diagnosis of either of the following:
      • Chronic migraine headache
      • Chronic probable migraine headache when the individual has experienced either:
        • Any two of the following pain criteria:
          1. Moderate-to-severe headache pain intensity
          2. Unilateral headache pain
          3. Pain aggravated by movement or pain that prohibits movement
          4. Throbbing headache pain
OR
        • One of the above pain criteria and one of the following associated symptoms:
          • Nausea
          • Sensitivity to light (photophobia) and sound (phonophobia)
AND
    • The individual has failed to respond to a 4-week course each of at least 2 agents from different classes of medications as noted below (at a minimally effective or maximally tolerated dose), if not contraindicated:
      • Tricyclic antidepressants (TCAs), e.g., amitriptyline, nortriptyline
      • Serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g., venlafaxine (Effexor), OR a single selective serotonin reuptake inhibitor (SSRI), e.g., fluoxetine (Prozac, Sarafem)
      • Anticonvulsants, e.g., divalproex sodium (Depakote), valproic acid (Depakene), valproate sodium (Depakene, Depacon), topiramate (Topamax), gabapentin (Neurontin)
      • Beta-blockers, e.g., propranolol (Inderal), atenolol (Tenormin), metoprolol (Lopressor, Toprol), nadolol (Corgard)
      • Calcium channel blockers, e.g., diltiazem (Cardizem, Dilacor, Taztia), nifedipine (Procardia, Adalat), verapamil (Calan, Verelan)
      • Any other drug proven to be effective to treat chronic migraine headache in a randomized, double-blind, placebo-controlled trial
    • Initial authorization for botulinum toxin A for chronic migraine headache/chronic probable migraine headache is for 2 cycles (24 weeks), and repeat authorization(s) for Botox® for chronic migraine headache and chronic probable migraine will be given only if the individual reports to the provider an improvement with its use, i.e., 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 recommended re-treatment cycle is every 12 weeks, and should be based on continued, sustained improvement that results specifically from this treatment.
  • 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, or if a contraindication to such treatments exist
  • Focal hand dystonia
  • Severe primary focal hyperhidrosis: in order to treat individuals whose condition is not adequately managed with topical agents (for treatment of palmar, plantar, or axillary hyperhidrosis) or iontophoresis (for treatment of palmar or plantar hyperhidrosis) or who have contraindications to such treatment, AND 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
  • Spasm, hemifacial
  • 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
  • Strabismus in visually mature individuals (older than ten years of age) 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.

MYOBLOC® (rimabotulinumtoxinB)

Myobloc® (rimabotulinumtoxinB) is considered medically necessary and, therefore, covered when any of the following criteria are met:
  • 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

MEDICALLY NECESSARY
Muscle spasm

Muscle spasm is considered a secondary diagnosis. The use of Botox® (onabotulinumtoxinA) Dysport® (abobotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), or Xeomin® (incobotulinumtoxinA) for muscle spasm is considered medically necessary and, therefore, covered only when the etiology is a direct result of one of the medically necessary conditions listed above.

Pediatric Individuals

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

NOT MEDICALLY NECESSARY
In the treatment of larger muscle groups, it is considered not medically necessary to continue treatment if no response is elicited with a maximum dose per site. Treatment may be resumed at a later date 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 Botox® (onabotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), and Xeomin® (incobotulinumtoxinA) not listed above as medically necessary 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.

COSMETIC SERVICES

The use of Botox® and Botox® Cosmetic (onabotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA) 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, Botox® (onabotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), Xeomin® (incobotulinumtoxinA), and Dysport® (abobotulinumtoxinA) 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

Botox® (onabotulinumtoxinA) 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.

Myobloc® (rimabotulinumtoxinB) 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.

Dysport® (abobotulinumtoxinA) 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 less than 65 years old. Supplemental approvals for Dysport® (abobotulinumtoxinA) have since been issued by the FDA.

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

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, there are four US Food and Drug Administration (FDA)--approved botulinum toxin products that are available in the United States: Botox® and Botox Cosmetic® (onabotulinumtoxinA, [Allergan]), Myobloc® (rimabotulinumtoxinB, [Solstice Neurosciences, Inc]), Dysport® (abobotulinumtoxinA, [Ipsen Biopharmaceuticals]), and Xeomin® (incobotulinumtoxinA [Merz Pharmaceuticals, Raleigh, NC]). 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): Botox® (onabotulinumtoxinA)
  • blepharospasm (abnormal tics and twitches of the eyelids): Botox® (onabotulinumtoxinA) in those ages 12 years and older, Xeomin® (incobotulinumtoxinA) in adults previously treated with [Botox®] onabotulinumtoxinA)
  • cervical dystonia (a condition that affects the muscles in the neck that control the position of the head): Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), and Xeomin® (incobotulinumtoxinA) (botulinum toxin-naive and previously treated individuals)
  • forehead lines associated with frontalis muscle activity (to temporarily improve the appearance): Botox Cosmetic® (onabotulinumtoxinA)
  • glabellar lines (to temporarily improve the appearance of frown lines between the eyebrows): Botox Cosmetic® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), and Xeomin® (incobotulinumtoxinA)
  • lateral canthal lines (crow's feet) associated with orbicularis oculi activity (to temporary improve the appearance): Botox Cosmetic® (onabotulinumtoxinA)
  • migraine, chronic: Botox® (onabotulinumtoxinA)
  • overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency: Botox® (onabotulinumtoxinA)
  • sialorrhea, chronic in adults: Xeomin® (incobotulinumtoxinA)
  • spasticity of lower limb: Botox® (onabotulinumtoxinA) in adults, Dysport® (abobotulinumtoxinA) in children 2 years of age and older and adults
  • spasticity of upper limb in adults: Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA) in adults, and Xeomin® (incobotulinumtoxinA)
  • strabismus (crossed eyes): Botox® (onabotulinumtoxinA) in those ages 12 years and older
  • urinary incontinence due to neurogenic bladder: Botox® (onabotulinumtoxinA)

On October 15, 2010, the FDA approved Botox® (onabotulinumtoxinA) for prophylaxis of headaches in adults with chronic migraine headache (at least 15 days per month with headache lasting at least 4 hours a 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 Botox® (onabotulinumtoxinA) 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.

Botox® and Botox® Cosmetic (onabotulinumtoxinA) 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, Myobloc (rimabotulinumtoxinB) and Dysport® (abobotulinumtoxinA) use a mechanism of like action to inhibit the release of acetylcholine.

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.
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Lexi-Drugs Compendium. incobotulinumtoxinA. 03/08/16. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/search?q=botulinum&t=name [via subscription only]. Accessed April 6, 2016.

Lexi-Drugs Compendium. OnabotulinumtoxinA. 02/24/16. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/search?q=botulinum&t=name [via subscription only]. Accessed April 6, 2016.

Lexi-Drugs Compendium. RimabotulinumtoxinB. 03/25/16. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/search?q=botulinum&t=name [via subscription only]. Accessed April 6, 2016.

Li VJ, Huang Y, Ding Q, et al. Evaluation of concentrations of botulinum toxin A for the treatment of hemifacial spasm: a randomized double-blind trial. Genet Mol Res. 2015;14:1136-1144.

Lipp A, Trottenberg T, Schink T, et al. A randomized trial of botulinum toxin A for treatment of drooling. Neurology. 2003;61(9):1279-1281.

Lipton RB. Methodologic issues in acute migraine clinical trials. Neurology. 2000;55(9 Suppl 2):S3-S7.

MacGregor EA, Brandes J, Eikermann A. Migraine prevalence and treatment patterns: The Global Migraine and Zolmitriptan Evaluation survey. Headache. 2003;43(1):19-26.

Myobloc® [prescribing information]. South San Francisco, CA: Solstice Neurosciences, Inc; 05/2010. Available at: https://www.myobloc.com/. Accessed August 24, 2018.

National Institute of Neurological Disorders and Stroke. Hemifacial spasm information page. Undated. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Hemifacial-Spasm-Information-Page#disorders-r1 . Accessed December 20, 2017.

Naumann MK, Hamm H, Lowe NJ. Botox Hyperhidrosis Clinical Study Group. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating. A randomized controlled trial. Br J Dermatol. 2002;147(6):1218-1226.

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.

Reddihough D, Erasmus CE, Johnson H, McKellar GM, Jongerius PH; Cereral Palsy Institute. Botulinum toxin assessment, intervention and aftercare for paediatric and adult drooling: international consensus statement. Eur J Neurol. 2010 Aug;17 Suppl 2:109-21. doi: 10.1111/j.1468-1331.2010.03131.x.

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.

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.

Scheffer AR, Erasmus C, van Hulst K, van Limbeek J, Jongerius PH, van den Hoogen FJ. Efficacy and duration of botulinum toxin treatment for drooling in 131 children. Arch Otolaryngol Head Neck Surg. 2010 Sep;136(9):873-7. doi: 10.1001/archoto.2010.147.

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.

Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000;55(6):754-762.

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.

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

Sokol T. Anal fissure. [MedicineNet Web Site]. Last reviewed 02/08/12. Available at: http://www.medicinenet.com/anal_fissure/article.htm. Accessed September 25, 2014.

Squires N, Humberstone M, Wills A, Arthur A. The use of botulinum toxin injections to manage drooling in amyotrophic lateral sclerosis/motor neurone disease: a systematic review. Dysphagia. 2014 Aug;29(4):500-8. doi: 10.1007/s00455-014-9535-8. Epub 2014 May 22.

Taqi D, Gunyea I, Bhakta B, et al. Botulinum toxin type B (Myobloc) in the treatment of refractory myofascial pain. Pain Med. 2002;3(2):174.

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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)



THE FOLLOWING CODE REPRESENTS BOTOX® (ONABOTULINUMTOXINA)

J0585 Injection, onabotulinumtoxina, 1 unit

THE FOLLOWING CODE REPRESENTS DYSPORT® (ABOBOTULINUMTOXINA)

J0586 Injection, abobotulinumtoxinA, 5 units

THE FOLLOWING CODE REPRESENTS MYOBLOC® (RIMABOTULINUMTOXINB)

J0587 Injection, rimabotulinumtoxinb, 100 units

THE FOLLOWING CODE REPRESENTS XEOMIN® (INCOBOTULINUMTOXINA)

J0588 Injection, otulinumtoxinA, 1 Unit



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 08.00.26u
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: 01/28/2019
Version Issued Date: 01/28/2019
Version Reissued Date: N/A

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