Botulinum Toxins

Jurisdiction: J9 MAC Part B. States: Florida, Puerto Rico, US Virgin Islands. Type: Active LCD

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Clostridium botulinum toxin describes a family of neurotoxins produced by the anaerobic bacteria of the species C. botulinum. There are 7 distinct serotypes of botulinum toxin: A, B, C, D, E, F and G. All botulinum neurotoxin serotypes are understood to produce their clinical effect by blocking the release of the neurotransmitters, principally acetylcholine, from nerve endings. 1 There are 5 distinct serotype A botulinum toxin products, onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), and daxibotulinum toxin A (Daxxify) and 1 serotype B botulinum toxin product, rimabotulinumtoxinB (Myobloc) that have been approved by the US Food and Drug Administration (FDA). Jeuveau is indicated for cosmetic use only. 2 Whether a botulinum toxin is produced from the same or a different serotype producing strain, they undergo different manufacturing processes which yield differences in the size and weight of the molecules. Because of this, Botox, Dysport, Xeomin, Myobloc, and Daxxify, as well as other botulinum toxin products available internationally, are not interchangeable. They are chemically, pharmacologically and clinically distinct. 1 Botulinum toxin injections are commonly used to treat a wide variety of conditions in which the main therapeutic effect is to decrease undesired or excessive contraction of striated or smooth (involuntary) muscle. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. 1 The resulting chemical-denervation of muscle produces local paresis or paralysis and allows individual muscles to be weakened selectively. The overall coverage of drugs is addressed in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 15, Sections 50.4.1 and 50.4.2 and includes coverage for FDA-approved drugs and unlabeled use of a drug. Covered Indications NOTE: The 5 botulinum therapies are not interchangeable and are only covered as listed below. Botulinum toxins (Botox, Dysport, Xeomin, Myobloc, and Daxxify), will be considered reasonable and necessary when administered for treatment of FDA-labeled indications and Off-label indications (as applicable) below: FDA 3 indications for onabotulinumtoxinA (Botox) as noted on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103000 Off-Label indications for onabotulinumtoxinA (Botox) are considered reasonable and necessary in patients for the following conditions: Esophageal achalasia in the following circumstances: Medically high-risk patients who cannot undergo other invasive treatments (peroral endoscopic myotomy [POEM], Heller myotomy, pneumatic dilation [PD]) 4,5,6,7,8,9,10,11,12 As a bridge for those awaiting more effective treatments such as Heller myotomy, pneumatic dilations or POEM 10 During work-up and treatment planning of definitive treatments for achalasia 13,14 Chronic anal fissure for patients with inadequate response to conservative or pharmacologic treatment 15 Essential hand tremor for patients with a high amplitude tremor that disrupts activities of daily living and have had inadequate response to oral pharmacotherapy such as propranolol and primidone 16 Focal hand and limb dystonia 16 Hemifacial spasm in adults (cranial nerve VII disorder) 16 Isolated oromandibular dystonia (also known as orofacial dystonia, isolated oromandibular dystonia, oromandibular dystonia, blepharospasm associated with orofacial dystonia, and Meige syndrome) in adults 17 Laryngeal dystonia (spastic dysphonia) for adductor type (ADSD) 16 Bothersome simple motor tics in adolescents and adults when the benefits of treatment outweigh the risks 18 Severely disabling or aggressive vocal tics in older adolescents and adults when the benefits of treatment outweigh the risks 18 FDA 19 indications for abobotulinumtoxinA (Dysport) as noted on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125274 Off-label indications for abobotulinumtoxinA (Dysport) may be considered reasonable and necessary in patients for the following conditions: Blepharospasm in adults 16,17 Hemifacial spasm in adults (cranial nerve VII disorder) 16 Isolated oromandibular dystonia (also known as orofacial dystonia, isolated oromandibular dystonia, oromandibular dystonia, blepharospasm associated with orofacial dystonia, and Meige syndrome) in adults 17 FDA 20 indications for incobotulinumtoxinA (Xeomin) as noted on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125360 FDA 21 indications for rimabotulinumtoxinB (Myobloc) as noted on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103846 FDA 22 indications for daxibotulinumtoxinA-lanm (Daxxify) as noted on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761127 . Limitations Localization procedures would not be expected for easily targeted muscles and, therefore, would not be considered reasonable and necessary. 17 Administration of onabotulinumtoxinA (Botox) for achalasia in the following circumstances is not considered reasonable and necessary: Patients with contraindications for botulinum toxin injections (BTI) or upper endoscopy. 23 Injection of botulinum toxin in the esophageal body. 6,8,9,10 Treatment of isolated lower limb dystonia and isolated exercise-associated lower limb dystonia is not considered reasonable and necessary. 24 Treatment of abductor spasmodic dysphonia is not considered reasonable and necessary. 25 Treatment of wrinkles, also called glabellar lines, smoker’s lines, crow’s feet, laugh lines and aging neck, using botulinum toxins, are considered cosmetic procedures and not covered under Medicare. Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.