Medical Policy: 05.01.02
Original Effective Date: May 1991
Reviewed: April 2015
Revised: April 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
This Prior Authorization request will be reviewed for medical necessity only. Benefits are subject to the terms and conditions of the patient’s contract. Please contact Wellmark customer service at the number on the patient’s card with benefit questions.
Botulinum toxin is a protein produced by the bacterium Clostridium Botulinum. There are seven distinct serotypes designated as type, A, B, C-1, D, E, F and G. Only Type A and Type B preparations are currently available in the United States. When administered intramuscularly, all botulinum toxins reduce muscle tone by interfering with the release of acetylcholine from nerve endings.
FDA-approved labeled indications are few, but botulinum toxin has been used for a wide variety of off-label indications.
Prior approval is required. Submit a prior approval/treatment request now .
Botulinum toxins may be considered medically necessary for the following FDA-labeled indications:
- Facial nerve (VII) disorders
- Cervical dystonia
- Spasticity in the flexor muscles of the elbows, wrist, and fingers in adults
- Overactive bladder
- Urinary incontinence
- Prophylaxis of chronic migraine headaches
FDA approved indication(s) specific to entity:
Axillary hyperhidrosis (severe), not adequately managed by topical agents
Strabismus and blepharospasm associated with dystonia
To treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults
Note - Spasiticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis. Botox has not been shown to be safe and effective treatment for other upper limb muscles, spasticity in the legs, or for treatment of fixed contracture - a condition that affects range of motion. Treatment with Botox is not intended to substitute for physical therapy or other rehabilitative care.
Prophylaxis of chronic migraine headaches (greater than or equal to 15 days per month lasting 4 hours a day or longer)
Detrusor Overactivity associated with a neurologic condition (such as spinal cord injury or multiple sclerosis) with an intolerance or inadequate response to anticholinergic agents
Overactive bladder in adults with intolerance or inadequate response to anticholinergic agents
Glabellar lines (cosmetic indication not covered)
Lateral canthal lines (cosmetic indication not covered)
The use of botulinum toxin may be considered medically necessary for off-label indication for the treatment of dystonia resulting in functional impairment or intractable pain in patients with any of the following hereditary, degenerative, or demyelinating diseases of the central nervous system:
- Organic writer's cramp
- Hereditary spastic paraplegia
- Neuromyelitis optica
- Orofacial dyskinesia
- Idiopathic torsion dystonia
- Symptomatic torsion dystonia
- Schilder's disease
- Cerebral palsy
- Spastic monoplegia, hemiplegia, paraplegia, or quadriplegia
- Oromandibular dystonia
- Spasmodic dysphonia
- Spasmodic torticollis
- Spasticity related to stroke
- Multiple sclerosis
The use of botulinum toxin may be considered medically necessary for the treatment of sialorrhea in patients who are refractory to, or unable to tolerate, systemic anticholinergics.
The use of botulinum toxin may be considered medically necessary for the treatment of chronic anal fissures.
The use of botulinum toxin may be considered medically necessary for the treatment of esophageal achalasia which has not responded to dilatation or if the patient is a poor surgical candidate.
The use of botulinum toxin may be considered medically necessary for the treatment of incontinence due to detrusor overreactivity (urge incontinence), either idiopathic or due to neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is inadequately controlled with anticholinergic therapy.
Effective November 1, 2010, the use of onabotulinum toxin A may be considered medically necessary for the prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headaches lasting four hours a day or longer).
Botulinum toxin is considered investigational and not medically necessary for treatments listed above if criteria is not met and for the treatment of the following, including, but not limited to:
As prophylaxis or acute treatment of all other types of migraine headache including, but not limited to, episodic migraine
As prophylaxis or acute treatment of all other types of headache including, but not limited to, chronic tension-type headache
- Chronic motor tic disorders
Tics associated with Tourette's Syndrome
Benign essential tremor
Chronic low back pain
Myofascial pain syndrome
Botulinum toxin is considered not medically necessary for treatment of the following indications:
- Other cosmetic conditions
- Botulinum toxin blocks neuromuscular conduction by binding to receptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine.
- When injected IM at therapeutic doses, botulinum toxin produces a partial chemical denervation of the muscle, resulting in a localized reduction in muscle activity.
- When injected intradermally, botulinum toxin produces temporary chemical denervation of the sweat gland resulting in local reduction in sweating.
Criteria for Initial Approval of onobotulinum A (Botox) for Chronic Migraine Prophylaxis:
- Diagnosis of chronic migraine with previous failure of two prophylactic migraine therapies for a duration of equal to or greater than 8 weeks for each therapy.
- Diagnosis of chronic migraine can be made with the following criteria from the International Headache Society (HIS) Classification ICHD-II. Chronic migraine headaches are described as occurring on 15 or more days per month for more than 3 months in the absence of medication overuse with TWO or more of the following:
- Pulsating quality
- Moderate or severe pain intensity
- Aggravation by or causing physical avoidance of routine physical activity
ONE or more of the following:
- Nausea and/or vomiting
- Sensitivity to both light (photophobia) and sound (phonophobia)
Criteria for Continuation of onobotulinum A (Botox) for Chronic Migraine Prophylaxis:
- Approval may be granted for 12 additional months of therapy if the patient exhibits a 50% reduction/improvement in chronic migraines since starting therapy with Botox.
Approval for the use of Botox in the treatment of chronic migraine headaches was based on two randomized, multi-center, 24 week, 2 injection cycle, placebo-controlled, double blind studies. These studies included patients that were not using concurrent medications for headache prophylaxis and had recorded headaches of greater than or equal to 15 days and lasting four hours or more in a 28 day cycle. Patients were allowed to use acute migraine treatment medications during the studies. In study 1, Botox (341 patients) demonstrated a decrease in frequency of headache days of 7.8 from baseline versus a decrease of 6.4 for placebo (338 patients) and 107 less cumulative hours of headache on headache days versus 70 hours for placebo. In Study 2, results were similar with Botox (347 patients) demonstrating a decrease of 9.2 headache days versus a decrease of 6.9 headaches for placebo (358 patients) and a cumulative decrease of 134 hours for Botox versus 95 hours cumulative hours for placebo. (p<0.05 for Botox differences from placebo).
Criteria for Approval for other conditions
Diagnosis of cervical dystonia.
Diagnosis of blepharospasm or strabismus associated with dystonia.
Diagnosis of a cranial nerve VII (seven) disorder (including Bell’s Palsy, Ramsay Hunt Syndrome, Melkersson-Rosenthal syndrome, and hemifacial spasms)
Diagnosis of dynamic muscle contracture in cerebral palsy.
Diagnosis of severe underarm sweating not adequately managed with topical agents
Diagnosis of severe plantar or palmar sweating not adequately managed with topical agents
Diagnosis of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults
Diagnosis of sialorrhea in patients who are refractory to OR unable to use anticholinergic medications
Diagnosis of esophageal achalasia in patients who have not responded to dilation OR who are poor surgical candidates
The following diagnoses will facilitate medical necessity:
Organic writer’s cramp
Hereditary spastic paraplegia
Idiopathic torsion dystonia
Symptomatic torsion dystonia
Spastic monoplegia, hemiplegia, paraplegia or quadriplegia
Chronic anal fissures
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 64612 Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (eg, for blepharospasm, hemifacial spasm)
- 64615 Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine)
- 64616 Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis)
- 64617 Chemodenervation of muscle(s); larynx, unilateral, percutaneous (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed
- 64642 Chemodenervation of one extremity; 1-4 muscle(s)
- 64643 Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) (List separately in addition to code for primary procedure)
- 64644 Chemodenervation of one extremity; 5 or more muscles
- 64645 Chemodenervation of one extremity; each additional extremity, 5 or more muscles (List separately in addition to code for primary procedure)
- 64646 Chemodenervation of trunk muscle(s); 1-5 muscle(s)
- 64647 Chemodenervation of trunk muscle(s); 6 or more muscles
- S2340 Chemodenervation of abductor muscle(s) of vocal cord
- S2341 Chemodenervation of adductor muscle(s) of vocal cord
- J0585 Injection, onabotulinumtoxinA, 1 unit
- J0586 Injection, abobotulinumtoxinA, 5 units
- J0587 Injection, rimabotulinumtoxinB, 100 units
- J0588 Injection, incobotulinumtoxinA, 1 unit
- Munchay, A., Bhatia, K.P. Uses of botulinum toxin injection in medicine today. BMJ2000;320:161-165.
- Yang Tusi-Fen, Chan Rai-Chi, Chuang Tien-yow, Liu Tacho-jen, Chiu Jan-wei. Treatment of cerebral palsy with botulinum toxin: evaluation with gross motor function measure. J Formosan Med Assoc 1999;vol 98(12):832-836.
- Russman BS, Tilton A, Gormley ME. Cerebral Palsy: A rational approach to a treatment protocol, and the role of botulinum toxin in treatment. Muscle Nerve 1997;20(Supplement 6): s181-s193.
- Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum toxin type A as a migraine preventive treatment. Headache2000;40:445-50
- 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;40:300-305
- Wheeler AH. Botulinum toxin A, adjunctive therapy for refractory headaches associated with pericranial muscle tension. Headache 1998; 38:468-471
- Freund BJ, Schwartz M. Treatment of chronic cervical-associated headache with botulinum A: A pilot study. Headache 2000;40:231-236
- Von Lindern JJ, Niederhagen B, Berge S, Appel T. Type A botulinum in the treatment of chronic facial pain associated with masticatory hyperactivity. J Oral Maxillofac Surg. 2003 Jul;61(7):774-8.
- Padberg M, De Brijn SF, de Haan RJ, Tavy DL. Treatment of chronic tension-type headache with botulinum toxin: a double-blind, placebo-controlled clinical trial. Cephalagia. 2004 Aug;24(8):675-80.
- Ascher B, Zakine B, Kestemont P, Baspeyras M et al., A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin A in the treatment of glabellar lines. J Am Acad Dermatol. 2004 Aug;51(2):223-33.
- Childers MK, Brashear A, Jozefcyzk P, et al., Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1063-9.
- Fernandez HH, Lannon MC, Trieschmann ME, Friedman JH. Botulinum toxin type B for gait freezing in Parkinson's disease. Med Sci Monit. 2004 Jul;10(7):CR282-4.
- Schulte-Mattler WJ, Krack P; BoNTTH Study Group. Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study. Pain. 2004 May;109(1-2):110-4.
- Dogu O, Apaydin d, Sevim S, Talas DU, Aral M. Ultrasound-guided versus 'blind' intraparotid injections of botulinum toxin-A for the treatment of sialorrhea in patients with Parkinson's disease. Clin Neurol Neirosurg. 2004 Mar;106(2):93-6.
- Relja M, Telearovic S. Botulinum toxin in tension-type headache. J Neurol. 2004 Feb; 251 Suppl 1:112-4.
- Naumann M, So Y, Argoff CE et al. 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; 70:1707-1714.
- Simpson DM, Gracies J-M, Graham HK et al. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 70:1691-1698.
- Simpson DM, Blitzer A, Brashear C et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): Report of the therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 70:1699-1706.
- Silberstein SD, Gobel H, Jensen R et al. Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study. Cephalgia 2006;26:790-800.
- Schurch B, de Seze M, Denys P et al. Botulinum toxin type A is a safe and effective treatment of neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol 2005; 174(1):196-200.
- Sinha D, Karri K, Arunkalaivanan AS. Applications of Botulinum toxin in urogynaecology. Eur J Obstet Gynecol Reprod Biol 2007; 133(1):4-11.
- Karsenty G, Denys P, Amarenco G et al. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol 2008; 53(2):275-87.
- Ghei M, Maraj BH, Miller R et al. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol 2005; 174(5):1873-7.
- Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial. J Urol 2007; 177(6):2231-6.
- Karsenty G, Baazeem A, Elzayat E et al. Injection of botulinum toxin type A in the urethral sphincter to treat lower urinary tract dysfunction: a review of indications, techniques and results. Can J Urol 2006; 13(2):3027-33.
- Maanum G, Jahnsen R, Stanghelle JK et al. Effects of botulinum toxin A on ambulant adults with spastic cerebral palsy: a randomized double-blind placebo-controlled trial. J Rehabil Med. 2011 Mar; 43(4):338-47.
- Shaw LC, Price CI, van Wijck FM et al. Botulinum Toxin for the Upper Limb after Stroke (BoTULS) Trial: effect on impairment, activity limitation, and pain. Stroke. 2011 May; 42(5):1371-9. Epub 2011 Mar 17.
- Herschorn S, Gajewski J, Ethans K et al. Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial. J Urol. 2011 Jun;185(6): 2229-35. Epub 2011 Apr 16.
- Cady RK, Schreiber CP, Porter JA et al. A multi-center double-blind pilot comparison of onobotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache. 2011 Jan;51(1):21-32. doi: 10.1111/j.1526-4610.2010.01796.x. Epub 2010 Nov 10.
- Langevin P, Lowcock J, Weber J et al. Botulinum toxin intramuscular injections for neck pain: a systematic review and metaanalysis. J Rheumatol. 2011 Feb; 38(2):203-14. Epub 2010 Dec 1.
- Botox® [package insert]. Irvine, CA: Allergan; September 2013
- Myobloc® [package insert]. South San Francisco, CA: Solstics Neurosciences, Inc. May 2010.
- Naumann M, Lowe NJ, Kumar CR, et. al. Botulinum toxin Type A is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch Dermatol. 2003; 139: 731-736
- Dysport [package insert]. Scottsdale, AZ: Medicis Aesthetics Inc. May 2012
- FDA news release, accessed on March 10, 2010.
- Xeomin® [package insert]. Greensboro, NC: Merz Pharmaceuticals, LLC; April 2013
- Silberstein SD, H. S. (2012). Evidence-based guideline update: Pharmacologic treatment of episodic migraine prevention in adults. Neurology , 1337-1345.
- International Headache Society (IHS) Classification ICHD-II. Chronic Migraine. http://ihs-classification.org/en/02_klassifikation/02_teil1/01.05.01_migraine.html.Accessed Marcy 11, 2015.
- Loder E, Burch R, Rizzoli P. The 2012 AHS/AAN Guidelines for Prevention of Episodic
Migraine: A Summary and Comparison with Other Recent Clinical Practice Guidelines.
Date Reason Action
November 2010 Interim revision Chronic migraine
April 2011 Annual review Policy renewed
March 2012 Annual review Policy renewed
March 2013 Annual review Policy renewed
May 2013 Interim review Policy revised
March 2014 Annual review Policy revised
March 2015 Annual review Policy revised
April 2015 Interim review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.