Status Active Medical and Behavioral Health Policy Section: Medicine Policy Number: II-16 Effective Date: 03/25/2015 Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are responsible for medical advice and treatment of patients. Members with specific health care needs should consult an appropriate health care professional. BOTULINUM TOXIN Description: Botulinum toxin is produced by the bacterium Clostridium botulinum and includes seven distinct serotypes. Type A is the most powerful of the subtypes and was the first to be developed for clinical use; Type B is also commercially available. The potency units of botulinum toxin products are specific to the preparation and assay method utilized. They are not interchangeable and, therefore, units of biological activity of one botulinum toxin product cannot be compared or converted into units of any other botulinum toxin products. Botulinum toxin injections cause muscle paralysis by acting at the peripheral nerve endings to block release of the neurotransmitter acetylcholine. Four botulinum toxin agents are commercially available in the United States. Three of these, onabotulinumtoxinA (Botox®, Botox® Cosmetic), abobotulinumtoxinA (Dysport®), and incobotulinumtoxinA (Xeomin®) are serotype A agents. One agent, rimabotulinumtoxinB (Myobloc®) is a serotype type B preparation. OnabotulinumtoxinA (Botox®) has been FDA-approved for the following: • Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain. • Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII (facial) nerve disorders in patients 12 years of age and above. • Treatment of upper limb spasticity in adult patients. • Prevention of chronic migraine headache in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer). • Severe primary axillary hyperhidrosis that is inadequately managed with topical agents in adult patients. Note: This indication is addressed in a separate policy (II-55 Hyperhidrosis Treatments). • Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication. • Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. OnabotulinumtoxinA (Botox® Cosmetic) has been FDA-approved for the following: • Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity in adult patients. • Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients. AbobotulinumtoxinA (Dysport®) has received FDA approval for treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients. Dysport® is also approved for temporarily improving the appearance of glabellar lines (wrinkles) in adults less than 65 years of age. IncobotulinumtoxinA (Xeomin®) consists of the pure neurotoxin without complexing proteins and is the only product that is stable at room temperature for up to 36 months. This agent is FDA-approved for: • Treatment of blepharospasm in adults who were previously treated with onabotulinumtoxinA (Botox®) • Treatment of adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxinnaïve and previously treated patients; and • Temporary improvement in the appearance of glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. RimabotulinumtoxinB (Myobloc®) is FDA-approved for treatment of cervical dystonia, to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. It is anticipated that rimabotulinumtoxinB will be used for the same range of off-label indications as Type A agents. After successful extended use of botulinum toxin (usually one of the botulinumtoxinA serotypes), some initial responders become nonresponders. Such secondary non-response may occur for a variety of reasons; one cause in a small percentage of patients is the development of antibodies that neutralize the activity of the administered botulinum toxin. These patients are likely to respond to another botulinum toxin type. A clinically useful assay for toxin-reactive antibodies would detect only neutralizing antibodies, as nonneutralizing antibodies can be present in the serum of patients who have not developed resistance to treatment. Assay formats best suited to the clinical laboratory, such as immunoprecipitation, western blot, or enzyme-linked immunosorbent assay, typically do not discriminate between neutralizing and non-neutralizing antibodies and would thus generate false-positive results in some patients. Policy: I. The use of botulinum toxin (A or B serotypes) may be considered MEDICALLY NECESSARY for any of the following: A. Cervical dystonia (spasmodic torticollis to decrease the severity of abnormal head position and neck pain.* B. Strabismus* or blepharospasm including benign essential blepharospasm or VII (facial) nerve disorders in patients 12 years of age and above* C. Upper limb spasticity* D. Dystonia/spasticity in patients with any of the following diseases of the central nervous system: 1. Focal dystonias: a. Focal upper limb dystonia (e.g., organic writer’s cramp) b. Oromandibular dystonia (e.g., orofacial dyskinesia, Meige syndrome) c. Laryngeal dystonia (adductor spasmodic dysphonia) d. Idiopathic (primary or genetic) torsion dystonia e. Symptomatic (acquired) torsion dystonia 2. Spastic conditions: a. Cerebral palsy b. Spasticity related to stroke c. Acquired spinal cord or traumatic brain injury d. Hereditary spastic paraplegia e. Spastic hemiplegia f. Neuromyelitis optica g. Multiple sclerosis or Schilder’s disease E. Esophageal achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates F. Sialorrhea (drooling) associated with Parkinson’s disease G. Chronic anal fissure H. Prevention (treatment) of chronic migraine headache in the following situations* 1. Initial 6-month trial in adult patients who a. Meet International Headache Classification (ICHD-2) diagnostic criteria for chronic migraine headache: • migraine headaches lasting at least 4 hours on at least 15 days per month; and • migraine headaches for at least 3 months; AND b. Have symptoms that persist despite adequate trials of at least 2 agents from different classes of medications used in the treatment of chronic migraine headaches, e.g. antidepressants, antihypertensives and antiepileptics. • Patients who have contraindications to preventive medications are not required to undergo a trial of these agents. 2. Continuing treatment beyond 6-months: a. Migraine headache frequency reduced by at least 7 days per month compared to pre-treatment level; OR b. Migraine headache duration reduced at least 100 hours per month compared to pre-treatment level. I. Urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication.* J. Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.* * FDA-approved indication for at least one of the agents. II. Retreatment for all indications, including prevention of migraine headache, is considered NOT MEDICALLY NECESSARY if the original treatment was determined to be not medically necessary. III. The use of all botulinum toxin agents is considered COSMETIC for the treatment of glabellar lines or wrinkles and other indications solely to improve appearance. IV. All other uses of botulinum toxin are considered INVESTIGATIVE including, but not limited to: A. Bell’s palsy B. Benign prostatic hyperplasia C. Chronic low back pain D. Chronic motor tic disorder, and tics associated with Tourette syndrome (motor tics) E. Depressive disorders F. Detrusor sphincteric dyssynergia G. Essential tremor H. Facial wound healing I. Gastroparesis J. Headaches, except as noted above for prevention (treatment) of chronic migraine headache K. Hirschsprung’s disease L. Internal anal sphincter (IAS) achalasia M. Interstitial cystitis N. Joint pain O. Lateral epicondylitis P. Mechanical neck disorders Q. Myofascial pain syndrome R. Neuropathic pain after neck dissection S. Pain after hemorrhoidectomy or lumpectomy T. Prevention of pain associated with breast reconstruction after mastectomy U. Raynaud’s disease/Raynaud’s phenomenon V. Sialorrhea (drooling), unless secondary to Parkinson’s disease W. Tinnitus X. Trigeminal neuralgia V. The use of assays to detect antibodies to botulinum toxin is considered INVESTIGATIVE due to a lack of evidence demonstrating a beneficial impact on health outcomes. Documentation Submission: The following documentation in the medical record is required for review of botulinum toxin for chronic migraine headache: A. The patient meets the criteria for migraine headache defined in section IH1; B. The agents from two different classes used to treat chronic migraine or contraindication to one or more of the medications; and C. For continued treatment beyond 6-months: Information from the medical record and or headache diary/log entries quantifying a reduction in migraine frequency or duration compared to baseline. Coverage: Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. Receipt of benefits is subject to all terms and conditions of the member’s summary plan description (SPD). As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Blue Cross reserves the right to revise, update and/or add to its medical policies at any time without notice. For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites. Refer to the Pre-Certification/Pre-Authorization section of the Medical Behavioral Health Policy Manual for the full list of services, procedures, prescription drugs, and medical devices that require Precertification/Pre-Authorization. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met. Coding: The following codes are included below for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. HCPCS: J0585 Injection, onabotulinumtoxinA, 1 unit J0586 Injection, abobotulinumtoxinA, 5 units J0587 Injection, rimabotulinumtoxinB, 100 units J0588 Injection, incobotulinumtoxinA, 1 unit Deleted Codes: C9278, Q2040 Policy History: Developed August 14, 2002 Most recent history: Revised February 8, 2012 Reviewed/Updated, no policy statement changes February 13, 2013 Revised March 12, 2014 Reviewed/Updated, no policy statement changes March 11, 2015 Cross Reference: Hyperhidrosis Treatments, II-55 Current Procedural Terminology (CPT®) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. Copyright 2015 Blue Cross Blue Shield of Minnesota.
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