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Medical Policy: 05.01.02
Original Effective Date: May 1991
Reviewed: April 2011
Revised: November 2010
Benefit Application
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.
Description:
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.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment request now. ( 75KB)
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Policy:
Botulinum toxins may be considered medically necessary for the following FDA-labeled indications:
- Strabismus
- Blepharospasm
- Facial nerve (VII) disorders
- Cervical dystonia
- Spasticity in the flexor muscles of the elbows, wrist, and fingers in adults
The use of botulinum toxin in the treatment of hyperhidrosis is addressed separately in policy 08.01.08; Treatment of Hyperhidrosis.
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 for the treatment of the following:
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Acute migraine
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As prophylaxis or acute treatment of all other types of migraine headache including, but not limited to, episodic migraine
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As prophylaxis or acute treatment of all other types of headache including, but not limited to, chronic tension-type headache
- Chronic motor tic disorders
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Tics associated with Tourette's Syndrome
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Benign essential tremor
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Chronic low back pain
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Myofascial pain syndrome
Botulinum toxin is considered not medically necessary for treatment of the following indications:
- Wrinkles
- Other cosmetic conditions
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 64612 Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (eg, for blepharospasm, hemifacial spasm)
- 64613 Chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia)
- 64614 Chemodenervation of muscle(s); extremity(s) and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)
- 46505 Chemodenervation of internal anal sphincter
- S2340 Chemodenervation of abductor muscle(s) of vocal cord
- S2341 Chemodenervation of adductor muscle(s) of vocal cord
- Electromyographic (EMG) guidance may be used to direct the injection of the botulinum toxin, particularly if the larynx or esophagus is treated. If so, EMG guidance is considered an integral part of the procedure and no additional reimbursement for EMG is warranted.
- Injection of the vocal cords is done in association with laryngoscopic guidance. The laryngoscopy is considered an integral part of the procedure and separate billing is not warranted.
- EMG will be allowed when billed in conjunction with the botulinum injection for the following diagnosis:
- Writer's cramp
- Spasmodic Dysphonia
- Dystonia
- Spasticity due to monoplegia, hemiplegia, paraplegia, or quadriplegia
- J0585 Injection, onabotulinumtoxinA, 1 unit
- J0586 Injection, abobotulinumtoxinA, 5 units
- J0587 Injection, rimabotulinumtoxinB, 100 units
- J0588 Injection, incobotulinumtoxinA, 1 unit
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- 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.
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Policy History:
Date Reason Action
November 2010 Interim revision Chronic migraine
added
April 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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