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1 Local Coverage Determination (LCD): Botulinum Toxins (L33274) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Contractor Information CONTRACTOR NAME CONTRACT TYPE CONTRACT NUMBER JURISDICTION STATE(S) First Coast Service Options, Inc. A and B MAC MAC A J - N Florida First Coast Service Options, Inc. A and B MAC MAC B J - N Florida First Coast Service Options, Inc. A and B MAC MAC A J - N Puerto Rico Virgin Islands First Coast Service Options, Inc. A and B MAC MAC B J - N Puerto Rico First Coast Service Options, Inc. A and B MAC MAC B J - N Virgin Islands LCD Information Document Information LCD ID L33274 Original Effective Date For services performed on or after 10/01/2015 Original ICD-9 LCD ID L28788 Revision Effective Date For services performed on or after 11/15/2018 LCD Title Botulinum Toxins Revision Ending Date Proposed LCD in Comment Period Retirement Date Source Proposed LCD Notice Period Start Date AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT codes, descriptions and other data only are copyright 2017 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply. Notice Period End Date Current Dental Terminology 2017 American Dental Association. All rights reserved. Created on 11/19/2018. Page 1 of 22

2 Copyright 2018, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) or Laryssa Marshall at (312) You may also contact us at CMS National Coverage Policy Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR [b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Transmittal 2147, Change Request 7299, dated February 4, 2011 CMS Transmittal 2150, Change Request 7319, dated February 4, 2011 CMS Transmittal 2174, Change Request 7342, dated March 18, 2011 CMS Transmittal 2185, Change Request 7343, dated March 25, 2011 CMS Transmittal 2278, Change Request 7540, dated August 19, 2011 CMS Manual System, Pub , Medicare Program Integrity Manual, Chapter 13, Section Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Clostridium botulinum toxin describes a family of neurotoxins produced by the anaerobic bacteria of the species C. botulinum. There are seven 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. There are three distinct serotype A botulinum toxin therapeutic products and one serotype B botulinum toxin product that have been approved by the U.S. Food and Drug Administration (FDA): Created on 11/19/2018. Page 2 of 22

3 OnabotulinumtoxinA (Botox ) AbobotulinumtoxinA (Dysport ) IncobotulinumtoxinA (Xeomin ) RimabotulinumtoxinB (Myobloc ) 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 and Myobloc, as well as other type A products available internationally, are not interchangeable. They are chemically, pharmacologically and clinically distinct. Please note the FDA labeling in each product s package insert states: Units of biological activity cannot be converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method. Botulinum toxin injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonias, spasms, twitches, etc. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. The resulting chemical-denervation of muscle produces local paresis or paralysis and allows individual muscles to be weakened selectively. Before consideration of coverage may be made it should be established that the patient has been unresponsive to conventional methods of treatments such as medication, physical therapy and other appropriate methods used to control and/or treat spastic conditions when applicable. It is expected that a patient will not receive continued injections of botulinum toxin if treatment failure occurs after 2 consecutive injections, using maximum dose for the size of the muscle. Payment will be allowed for one injection per site regardless of the number of injections made into the site. A site is defined as including muscles of a single contiguous body part, such as, a single limb, eyelid, face, neck, etc. Botulinum toxins (Botox, Dysport, Xeomin and Myobloc, will be considered medically reasonable and necessary when administered for treatment of the following FDA-labeled indications and other indications as specified below: FDA Indications for Botox : Coverage of Botox for certain lower limb spasticity conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries and multiple sclerosis) will be limited to those conditions listed in the Covered ICD-10-CM section of this LCD. All other uses in the treatment of other types of spasm, including smooth muscle types, will be considered as investigational and therefore, noncovered. strabismus and blepharospasm associated with dystonia benign essential blepharospasm facial nerve (cranial nerve VII) disorders in patients 12 years of age and older cervical dystonia to reduce the severity of abnormal head position and neck pain (i.e., spasmodic torticollis) severe primary axillary hyperhidrosis inadequately managed with topical agents. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) and finger flexors (flexor digitorum profundus and flexor digitorum sublimis). prophylaxis of headaches in adult patients with chronic migraine (> 15 days per month with headache lasting 4 hours a day or longer). Created on 11/19/2018. Page 3 of 22

4 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 anticholinergic medication. Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Lower limb spasticity in adult patients to decrease the severity of lower limb spasticity (i.e., increased muscle tone) in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus): spastic hemiplegia spasticity related to stroke Off-label Indications for Botox : Botox is used for a wide range of off-label uses. The use of Botox may be considered a medically necessary offlabel indication for the treatment of dystonia or lower limb spasticity resulting in functional impairment (interference with joint function, mobility) and/or pain in patients with any of the following hereditary, acquired, degenerative, or demyelinating diseases of the central nervous system: dynamic muscle contracture in pediatric or adult cerebral palsy patients synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration (e.g., hemi facial spasm) idiopathic torsion dystonia symptomatic torsion dystonia oromandibular dystonia spasmodic dysphonia orofacial dyskinesia focal hand dystonia (e.g., writer s cramp) hereditary spastic paraplegia neuromyelitis optica Schilder s disease The use of Botox may be considered medically necessary in patients with laryngeal spasm and torticollis (whether congenital, due to child birth injury, or traumatic). The use of Botox may be considered medically necessary in patients with achalasia who have not responded to dilation therapy or who are considered poor surgical candidates. The use of Botox may be considered medically necessary as treatment of chronic anal fissure. Treatment of gustatory hyperhidrosis (secondary) with Botox may be considered medically necessary in patients with medical complications; such as skin maceration with secondary infections, or significant functional impairments. FDA Indication for Dysport : the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients; the treatment of spasticity in adults; the treatment of lower limb spasticity in pediatric patients 2 years of age and older. Off-label Indications for Dysport : Created on 11/19/2018. Page 4 of 22

5 benign essential blepharospasm hemifacial spasm in adults (ICD-10-CM code G24.4) severe primary axillary hyperhidrosis inadequately managed with topical agents. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. FDA Indications for Xeomin : chronic sialorrhea in adult patients adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients blepharospasm in adults previously treated with onabotulinumtoxina (Botox) upper limb spasticity in adult patients FDA Indications for Myobloc : cervical dystonia to reduce the severity of abnormal head position and neck pain (i.e., spasmodic torticollis) A USPDI revision dated December 5, 2005, reversed their decision to allow treatment of spasticity caused by stroke or brain injury listing under Acceptance not established. The USPDI revision further states, The data describing the treatment of Botulinum toxin type B for upper limb spasticity are limited and inconclusive. In a single, randomized, placebo-controlled trail, BTX-B did not demonstrate a benefit in reducing muscle tone in the elbow, wrist or finger flexors in post-stroke patients. However, improvements in upper limb spasticity were reported in a few small openlabeled trials presented in abstract and/or poster forms. Therefore, effective 11/01/2006, this indication will no longer be allowed. Off-label Indications for Myobloc : sialorrhea The treatment of sialorrhea due to conditions such as motor neuron disease or Parkinson's disease in those patients who have failed to respond to a reasonable trial of traditional therapies (eg., anticholinergics and speech therapy) or who have a contraindication to or cannot tolerate anticholinergic therapy, will be allowed for coverage. Summary of Evidence Analysis of Evidence (Rationale for Determination) Created on 11/19/2018. Page 5 of 22

6 Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. CODE 013x Hospital Outpatient 021x Skilled Nursing - Inpatient (Including Medicare Part A) 075x 085x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF) Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. CODE 0636 Pharmacy - Drugs Requiring Detailed Coding CPT/HCPCS Codes Group 1 Paragraph: Group 1 Codes: CODE J0585 INJECTION, ONABOTULINUMTOXINA, 1 UNIT Group 2 Paragraph: Group 2 Codes: CODE J0586 INJECTION, ABOBOTULINUMTOXINA, 5 UNITS Group 3 Paragraph: Created on 11/19/2018. Page 6 of 22

7 Group 3 Codes: CODE J0587 INJECTION, RIMABOTULINUMTOXINB, 100 UNITS Group 4 Paragraph: Group 4 Codes: CODE J0588 INJECTION, INCOBOTULINUMTOXIN A, 1 UNIT ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: Procedure Code J0585- Injection, onabotulinumtoxina, 1 unit Group 1 Codes: ICD-10 CODE G04.1 Tropical spastic paraplegia G11.4 Hereditary spastic paraplegia G24.09 Other drug induced dystonia G24.1 Genetic torsion dystonia G24.2 Idiopathic nonfamilial dystonia G24.3 Spasmodic torticollis G24.4 Idiopathic orofacial dystonia G24.5 Blepharospasm G24.8 Other dystonia G24.9 Dystonia, unspecified G25.89 Other specified extrapyramidal and movement disorders G35 Multiple sclerosis G G37.9 Neuromyelitis optica [Devic] - Demyelinating disease of central nervous system, unspecified G Chronic migraine without aura, intractable, with status migrainosus G Chronic migraine without aura, intractable, without status migrainosus G G51.8 Melkersson's syndrome - Other disorders of facial nerve G80.0 Spastic quadriplegic cerebral palsy Created on 11/19/2018. Page 7 of 22

8 ICD-10 CODE G80.1 Spastic diplegic cerebral palsy G80.2 Spastic hemiplegic cerebral palsy G80.3 Athetoid cerebral palsy G80.4 Ataxic cerebral palsy G80.8 Other cerebral palsy G80.9 Cerebral palsy, unspecified G G81.14 Spastic hemiplegia affecting right dominant side - Spastic hemiplegia affecting left nondominant side G G82.22 Paraplegia, unspecified - Paraplegia, incomplete G G82.54 Quadriplegia, unspecified - Quadriplegia, C5-C7 incomplete G83.0 Diplegia of upper limbs G G83.14 Monoplegia of lower limb affecting unspecified side - Monoplegia of lower limb affecting left nondominant side G G83.24 Monoplegia of upper limb affecting unspecified side - Monoplegia of upper limb affecting left nondominant side G G83.34 Monoplegia, unspecified affecting unspecified side - Monoplegia, unspecified affecting left nondominant side H H49.43 Third [oculomotor] nerve palsy, unspecified eye - Progressive external ophthalmoplegia, bilateral H H Other paralytic strabismus, right eye - Other paralytic strabismus, unspecified eye H49.9 Unspecified paralytic strabismus H H50.9 Unspecified esotropia - Unspecified strabismus H H51.9 Palsy (spasm) of conjugate gaze - Unspecified disorder of binocular movement I I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right dominant side - Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting right dominant side - Other paralytic syndrome following nontraumatic subarachnoid hemorrhage, bilateral Created on 11/19/2018. Page 8 of 22

9 ICD-10 CODE I I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right dominant side - Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting right dominant side - Other paralytic syndrome following nontraumatic intracerebral hemorrhage, bilateral I I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side - Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant side - Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting right dominant side - Other paralytic syndrome following other nontraumatic intracranial hemorrhage, bilateral I I Monoplegia of upper limb following cerebral infarction affecting right dominant side - Monoplegia of upper limb following cerebral infarction affecting left non-dominant side I I Monoplegia of lower limb following cerebral infarction affecting right dominant side - Monoplegia of lower limb following cerebral infarction affecting left non-dominant side I I Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side - Hemiplegia and hemiparesis following cerebral infarction affecting left nondominant side I I Other paralytic syndrome following cerebral infarction affecting right dominant side - Other paralytic syndrome following cerebral infarction, bilateral I I Monoplegia of upper limb following other cerebrovascular disease affecting right dominant side - Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant side I I Monoplegia of lower limb following other cerebrovascular disease affecting right Created on 11/19/2018. Page 9 of 22

10 ICD-10 CODE dominant side - Monoplegia of lower limb following other cerebrovascular disease affecting left non-dominant side I I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant side - Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant side I I Monoplegia of upper limb following unspecified cerebrovascular disease affecting right dominant side - Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non-dominant side I I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right dominant side - Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non-dominant side I I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right dominant side - Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non-dominant side J38.5 Laryngeal spasm J38.7 Other diseases of larynx K22.0 Achalasia of cardia K59.4 Anal spasm K K60.2 Acute anal fissure - Anal fissure, unspecified L L Primary focal hyperhidrosis, axilla - Primary focal hyperhidrosis, unspecified L74.52 Secondary focal hyperhidrosis M43.6 Torticollis N N31.1 Uninhibited neuropathic bladder, not elsewhere classified - Reflex neuropathic bladder, not elsewhere classified N31.9 Neuromuscular dysfunction of bladder, unspecified N32.81 Overactive bladder N36.44 Muscular disorders of urethra N39.41 Urge incontinence N39.46 Mixed incontinence Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: * These ICD-10-CM codes are to be used when there is spasticity of central nervous system origin. All the codes within the asterisked range from the first code to the last code apply. Group 2 Paragraph: Procedure code J0586- Injection, abobotulinumtoxina, 5 units Created on 11/19/2018. Page 10 of 22

11 Group 2 Codes: ICD-10 CODE G11.4 Hereditary spastic paraplegia G24.3 Spasmodic torticollis G24.4 Idiopathic orofacial dystonia G24.5 Blepharospasm G80.0 Spastic quadriplegic cerebral palsy G80.1 Spastic diplegic cerebral palsy G80.2 Spastic hemiplegic cerebral palsy G80.8 Other cerebral palsy G G81.14 Spastic hemiplegia affecting right dominant side - Spastic hemiplegia affecting left nondominant side G G82.22 Paraplegia, complete - Paraplegia, incomplete G G82.52 Quadriplegia, C1-C4 complete - Quadriplegia, C1-C4 incomplete G82.53 Quadriplegia, C5-C7 complete G82.54 Quadriplegia, C5-C7 incomplete G83.0 Diplegia of upper limbs G G83.14 Monoplegia of lower limb affecting right dominant side - Monoplegia of lower limb affecting left nondominant side G G83.24 Monoplegia of upper limb affecting right dominant side - Monoplegia of upper limb affecting left nondominant side I I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right dominant side - Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right dominant side - Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side Created on 11/19/2018. Page 11 of 22

12 ICD-10 CODE I I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side - Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant side - Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following cerebral infarction affecting right dominant side - Monoplegia of upper limb following cerebral infarction affecting left non-dominant side I I Monoplegia of lower limb following cerebral infarction affecting right dominant side - Monoplegia of lower limb following cerebral infarction affecting left non-dominant side I I Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side - Hemiplegia and hemiparesis following cerebral infarction affecting left nondominant side I I Monoplegia of upper limb following other cerebrovascular disease affecting right dominant side - Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant side I I Monoplegia of lower limb following other cerebrovascular disease affecting right dominant side - Monoplegia of lower limb following other cerebrovascular disease affecting left non-dominant side I I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant side - Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant side L L Primary focal hyperhidrosis, axilla - Primary focal hyperhidrosis, unspecified M43.6 Torticollis M M Contracture of muscle, right thigh - Contracture of muscle, left thigh M M Contracture of muscle, right lower leg - Contracture of muscle, left lower leg M M Contracture of muscle, right ankle and foot - Contracture of muscle, left ankle and foot M62.48 Contracture of muscle, other site M62.49 Contracture of muscle, multiple sites Created on 11/19/2018. Page 12 of 22

13 ICD-10 CODE M Muscle spasm of calf M Other muscle spasm Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: *These ICD-10-CM codes are to be used when there is spasticity of central nervous system origin. All the codes within the asterisked range from the first code to the last code apply. Group 3 Paragraph: Procedure Code J0587-Injection, rimabotulinumtoxinb, 100 units Group 3 Codes: ICD-10 CODE G24.3 Spasmodic torticollis K11.7 Disturbances of salivary secretion M43.6 Torticollis Group 4 Paragraph: Procedure code J Injection, incobotulinumtoxina, 1 unit Group 4 Codes: ICD-10 CODE G24.3 Spasmodic torticollis G24.5 Blepharospasm G80.0 Spastic quadriplegic cerebral palsy G80.1 Spastic diplegic cerebral palsy G80.2 Spastic hemiplegic cerebral palsy G G81.14 Spastic hemiplegia affecting right dominant side - Spastic hemiplegia affecting left nondominant side G82.53 Quadriplegia, C5-C7 complete G82.54 Quadriplegia, C5-C7 incomplete G83.0 Diplegia of upper limbs G G83.24 Monoplegia of upper limb affecting right dominant side - Monoplegia of upper limb affecting left nondominant side I I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side Created on 11/19/2018. Page 13 of 22

14 ICD-10 CODE I I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side - Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side - Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant side - Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant side I I Monoplegia of upper limb following cerebral infarction affecting right dominant side - Monoplegia of upper limb following cerebral infarction affecting left non-dominant side I I Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side - Hemiplegia and hemiparesis following cerebral infarction affecting left nondominant side I I Monoplegia of upper limb following other cerebrovascular disease affecting right dominant side - Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant side I I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant side - Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant side K11.7 Disturbances of salivary secretion M43.6 Torticollis Group 4 Medical Necessity ICD-10 Codes Asterisk Explanation: *These ICD-10-CM codes are to be used when there is spasticity of central nervous system origin. All the codes within the asterisked range from the first code to the last code apply. ICD-10 Codes that DO NOT Support Medical Necessity Additional ICD-10 Information Created on 11/19/2018. Page 14 of 22

15 General Information Associated Information Documentation Requirements Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of botulinum toxin by clearly indicating the condition for which this drug is being used. This documentation is usually found in the history and physical or in the office/progress notes and should include the following elements in the event of a post payment review: support for the medical necessity of the botulinum toxin injection. a covered diagnosis. documentation of unsuccessful conventional methods of treatment such as the timing and duration of medication, and/or physical therapy, and/or other appropriate methods used to control and/or treat spastic conditions (statement outlining specific past history is acceptable). dosage and frequency of the injections. support for the medical necessity of electromyography procedures. support of the clinical effectiveness of the injections. specify the site(s) injected. when Botox (onabotulinumtoxina) is used for the FDA approved indication of prophylaxis of headaches in adult patients with chronic migraine (> 15 days per month with headache lasting 4 hours a day or longer), the documentation must support these specific symptom parameters. Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity. Sources of Information First Coast Service Options, Inc. reference LCDs: L28790, L29088, L29103 Allergan Pharmaceutical Manufacturers Package Insert American Medical Association. (1998). Coding consultation. CPT Assistant, 8(10), 10. This article further clarified the use of procedure codes American Medical Association. (2001). Chemodenervation. CPT Assistant, 11(4), 1-2. The article further defined the use of procedure codes Aoki, K. (2001). A comparison of the safety margins of botulinum neurotoxin serotypes A, B, and F in mice. Elsevier Science, 39(12), Brashear, A. (2003). Dosing of Botox and Myobloc: Consensus and Controversies. Practical Neurology, September, Created on 11/19/2018. Page 15 of 22

16 Brashear, A., Watts, M. Marchetti, A., Magar, R., Lau, H., Wang, L (2000). Duration of effect of botulinum type A in adult patients with cervical dystonia: A retrospective chart review. Clinical Therapeutics, 22(12), Brubaker, L., Richter, H., Visco, A., Mahajan, S., Nygaard, I., Braun, T., Barber, M., Menefee, S., Schaffer, J., Weber, A., & Wei, J. (2008). Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol, 180, Callaway, J., Arezzo, J., Grethlein, A. (2002). Botulinum toxin type B: An overview of its biochemistry and preclinical pharmacology. Disease-A-Month, 48(5). Retrieved October 6, 2003 from mdconsult database ( ). Dysport (abobotulinumtoxina) prescribing information. Ipsen Biopharm Ltd. Lowe, N., Yamauchi, P., Lask, G., Patnaik, R., Iyer, S. (2003). Efficacy and safety of botulinum toxin type A in the treatment of palmar hyperhidrosis: A double-blind, randomized, placebo-controlled study. American Society for Dermatologic Surgery, 28(9), Mosby s Drug Consult. (2003). Botulinum Toxin. Retrieved October 2, 2003, from mdconsult database ( /1/514). Myobloc (rimabotulinumtoxinb) prescribing information. Solstice Neurosciences, Inc. Naumann, M., Lowe, N., Kumar, C., Hamm, H., (2003). Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months. Arch Dermatol, 139, Naumann, M., Lowe, N., (2001). Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomized, parallel group, double blind, placebo controlled trial. British Medical Journal, 323, O Brien, C. (2002). Treatment of spasticity with botulinum toxin. The Clinical Journal of Pain. 18, Ondo WG, Hunter, Moore (2004). A double -blind placebo-controlled trial of Botulinum toxin B for sialorrhea in Parkinson s disease. Neurology, 62(1):37-40 U.S. Food and Drug Administration (FDA) Drug Alert. (08/2009). Information for Healthcare Professionals: onabotulinumtoxina,(marketed as Botox/Botox Cosmetic) abobotulinumtoxina (marked as Dysport) and rimabotulinumtoxinb (marketed as Myobloc). Retrieved on September 2, U.S. Food and Drug Administration (FDA) prescribing information for Botox. (2013). U.S. Food and Drug Administration (FDA) prescribing information for Dysport. (09/2017) U.S. Food and Drug Administration (FDA) prescribing information for Xeomin. (07/2018) U.S. Food and Drug Administration (FDA). (2011). Department of Health and Human Services. CDER web sites updates. USPDI Compendia Update Thomson MICROMEDEX. December 5, Verheyden, J., Blitzer, A. (2002). Other noncosmetic uses of botox. Disease-A-Month, 48(5). Retrieved October 6, 2003 from mdconsult database ( ). Ward, A., Aguilar, M., DeBey, Z., Gedin, S., Kanovsky, P., Molteni, F., Wissel, J., Yakovieff, A. (2003). Use of botulinum toxin type A in management of adult spasticity A European consensus statement. J Rehabil Med, 35(2), Created on 11/19/2018. Page 16 of 22

17 Xeomin (incobotulinumtoxina) prescribing information. Merz Group Services GmbH. Bibliography Revision History Information EXPLANATION REASON(S) FOR CHANGE DATE NUMBER 11/15/2018 R9 Revision Number: 7 Publication: November 2018 Connection LCR A/B Reconsideration Request Explanation of Revision: Based on a LCD reconsideration request, the Coverage Indications, Limitations, and/or Medical Necessity section of the LCD under FDA indications for Xeomin : was revised to add the FDA indication chronic sialorrhea in adult patients. Also, the ICD-10 Codes that Support Medical Necessity section of the LCD was revised to add ICD-10-CM diagnosis code K11.7 to the Group 4 Codes that support medical necessity for procedure code J0588 (Injection, incobotulinumtoxin A, 1 unit). In addition, the Sources of Information section of the LCD was updated to include the published source from the reconsideration request. This revision to the LCD is effective for claims processed on or after 11/15/2018, for dates of service on or after 07/03/ /15/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD. 10/01/2018 R8 Revision Number: 6 Explanation of Revision: Based on CR (Annual 2019 ICD-10-CM Update), the LCD was revised to indicate that diagnosis codes were added and deleted within existing diagnosis code ranges. The effective date of this revision is based on date of service. Revisions Due To ICD-10-CM Code Changes 05/03/2018 R7 Revision Number: 5 Reconsideration Request Created on 11/19/2018. Page 17 of 22

18 EXPLANATION REASON(S) FOR CHANGE DATE NUMBER Publication: May 2018 Connection LCR A/B Explanation of revision: Based on an LCD reconsideration request, this LCD was revised in the Coverage Indications, Limitations, and/or Medical Necessity section to include the FDA indications for Dysport the treatment of spasticity in adults and the treatment of lower limb spasticity in pediatric patients 2 years of age and older. In addition, the accompanying diagnosis codes (G11.4, G80.8, G82.21-G82.22, G82.51-G82.52, G83.11-G83.14, I I69.044, I I69.144, I I69.244, I I69.344, I I69.844, M M62.452, M M62.462, M M62.472, M62.48, M62.49, M62.831, and M62.838) for these indications were added to the ICD-10 Codes that Support Medical Necessity section under Group 2 Codes: and the Sources of Information and Basis for Decision has also been updated. The LCD revision to include the treatment of lower limb spasticity in pediatric patients 2 years of age and older is effective for claims processed on or after May 3, 2018, for dates of service on or after 07/29/2016. The LCD revision to include the treatment of spasticity in adults is effective for claims processed on or after May 3, 2018, for dates of service on or after June 14, /03/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy. 02/08/2018 R6 Revision Number: 4 Publication: February 2018 Connection Provider Education/Guidance Public Education/Guidance LCR A/B Explanation of revision: This LCD has been revised to include an explanation that all the codes within the asterisked range from the first code to the last code apply for ICD-10 code ranges in the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure codes J0585, J0586 and J0588. In addition, the procedure codes in the CPT/HCPCS Created on 11/19/2018. Page 18 of 22

19 EXPLANATION REASON(S) FOR CHANGE DATE NUMBER Codes section of the LCD were put in groups to be consistent with the groups in the ICD-10 Codes that Support Medical Necessity section of the LCD. The effective date of this revision is based on process date. 02/08/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy. 06/09/2016 R5 Revision Number: 3 Publication: June 2016 Connection LCR A/B Typographical Error Explanation of revision: Based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G83.21-G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0586. Additionally, language clarifying the asterisked diagnoses was also added to this section. Also, spasticity of the arm in patients following a stroke was removed from the Off-label Indications section for Dysport. The effective date of this revision is for dates of service on or after 06/09/16. This LCD was also revised to add ICD-10-CM code range G G81.14 under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for claims processed on or after 06/09/16, for dates of service on or after 12/22/2015. In addition, based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for dates of service on or after 06/09/16. Created on 11/19/2018. Page 19 of 22

20 EXPLANATION REASON(S) FOR CHANGE DATE NUMBER 06/09/2016 R4 Revision Number: 3 Publication: June 2016 Connection LCR A/B Typographical Error 06/09/2016 R3 Explanation of revision: Based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G83.21-G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0586. Additionally, language clarifying the asterisked diagnoses was also added to this section. Also, spasticity of the arm in patients following a stroke was removed from the Off-label Indications section for Dysport. The effective date of this revision is for dates of service on or after 06/09/16. This LCD was also revised to add ICD-10-CM code range G G81.14 under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for claims processed on or after 06/09/16, for dates of service on or after 12/22/2015. In addition, based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for dates of service on or after 06/09/16. Revision Number: 3 Publication: June 2016 Connection LCR A/B Revisions Due To ICD-10-CM Code Changes Explanation of revision: Based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G83.21-G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Created on 11/19/2018. Page 20 of 22

21 EXPLANATION REASON(S) FOR CHANGE DATE NUMBER Medical Necessity section of the LCD for procedure code J0586. Additionally, language clarifying the asterisked diagnoses was also added to this section. Also, spasticity of the arm in patients following a stroke was removed from the Off-label Indications section for Dysport. The effective date of this revision is for dates of service on or after 06/09/16. This LCD was also revised to add ICD-10-CM code range G G81.14 under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for claims processed on or after 06/09/16, for dates of service on or after 12/22/2015. In addition, based on an LCD reconsideration request, this LCD was revised to add ICD-10-CM codes G80.0, G80.1, G80.2, G82.53, G82.54, G83.0*, and ICD-10-CM code ranges G G83.24*, I I69.034, I I69.054, I I69.134, I I69.154, I I69.234, I I69.254, I I69.334, I I69.354, I I69.834, and I I under the ICD-10 Codes that Support Medical Necessity section of the LCD for procedure code J0588. The effective date of this revision is for dates of service on or after 06/09/16. 03/29/2016 R2 Revision Number: 2 Publication: March 2016 Connection LCR A/B Reconsideration Request Explanation of revision: Based on an LCD reconsideration request, this LCD was revised to include the FDA indication for Xeomin upper limb spasticity in adult patients under the Indications and Limitations of Coverage and/or Medical Necessity section of the LCD. The effective date of this revision is for claims processed on or after 3/29/2016, for dates of service on or after 12/22/2015. This LCD was also revised based on LCD reconsideration request to include the FDA indication for Botox - lower limb spasticity in adult patients under the Indications and Limitations of Coverage and/or Medical Necessity section. In addition spastic hemiplegia, and spasticity related to stroke were removed from the Off label Indications for Botox and added to the FDA Indications for Botox section of the LCD. Also, the ICD-10-CM codes G80.1, I I69.065, I I69.165, I I and I I were added under ICD- 10 Codes that Support Medical Necessity for procedure code J0585. The effective date of this revision is for claims Created on 11/19/2018. Page 21 of 22

22 EXPLANATION REASON(S) FOR CHANGE DATE NUMBER processed on or after 03/29/2016, for dates of service on or after 01/21/ /23/2016 R1 Revision Number: 1 Publication: March 2016 Connection LCR A/B Explanation of revision: Based on an LCD reconsideration request, this LCD was revised to include FDA indication for Dysport upper limb spasticity in adult patients under the Indications and Limitations of Coverage and/or Medical Necessity section of the LCD. The effective date of this revision is for claims processed on or after 02/23/2016, for dates of service on or after 07/15/15 Provider Education/Guidance New/Updated Technology Associated Documents Attachments Related Local Coverage Documents Article(s) A Botulinum toxins revision to the Part A and B LCD Related National Coverage Documents Public Version(s) Updated on 11/08/2018 with effective dates 11/15/ Updated on 10/03/2018 with effective dates 10/01/ /14/2018 Updated on 04/27/2018 with effective dates 05/03/ /30/2018 Updated on 02/02/2018 with effective dates 02/08/ /02/2018 Updated on 06/23/2016 with effective dates 06/09/ /07/2018 Updated on 06/09/2016 with effective dates 06/09/ Updated on 06/03/2016 with effective dates 06/09/ Some older versions have been archived. Please visit the MCD Archive Site to retrieve them. Keywords Created on 11/19/2018. Page 22 of 22