Botulinum Toxin*

Medical Policy: 05.01.02 
Original Effective Date: May 1991 
Reviewed: October 2008 
Revised: October 2008 

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

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.

Prior Approval is recommended.  Submit a prior approval/treatment request now.

Policy: 

Botulinum toxins may be considered medically necessary for the following FDA-labeled indications: 
  • Strabismus
  • Blepharospasm
  • Facial Nerve (VII) disorders
  • Cervical Dystonia

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 a medically necessary 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

Effective January 1, 2009, the use of botulinum toxin will be considered investigational for all headache types including migraine.

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 refractory migraine headache in patients meeting ALL of the following criteria:

  • History of treatment failure of a least 3 prophylactic regimens, i.e. calcium channel blockers, beta blockers, NSAIDS, SSRIs, and triptans
  • Under the care of a neurologist for migraine headache
  • Documented significant functional disability, i.e. work absenteeism, multiple ED visits

Botulinum toxin is considered investigational and not a covered benefit for the treatment of the following:

  • All headache types except migraine as outlined above 
  • 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:

  • Wrinkles
  • Other cosmetic conditions 


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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
  • To report chemodenervation procedures use CPT codes 64612; 64613; 64614; 67345; or HCPCS code S2340 and S2341 as appropriate.
  • 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 
  • Botulinum Toxin A, per unit, may be reported with HCPCS code J0585
  • Botulinum Toxin B, per 100 units, may  be reported with HCPCS code J0587

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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. 

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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:

Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave.
Des Moines, IA 50309

*Prior Approval is recommended.

**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.

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.