Contractor Information. LCD Information. Local Coverage Determination (LCD): Chemodenervation (L33458) Document Information

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1 Local Coverage Determination (LCD): Chemodenervation (L33458) 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) Palmetto GBA A and B MAC MAC B J - J Alabama Palmetto GBA A and B MAC MAC B J - J Georgia Palmetto GBA A and B MAC MAC B J - J Tennessee Palmetto GBA A and B and HHH MAC MAC B J - M South Carolina Palmetto GBA A and B and HHH MAC MAC B J - M Virginia Palmetto GBA A and B and HHH MAC MAC B J - M West Virginia Palmetto GBA A and B and HHH MAC MAC B J - M North Carolina Back to Top LCD Information Document Information LCD ID L33458 Original ICD-9 LCD ID L31701 LCD Title Chemodenervation Proposed LCD in Comment Period N/A Source Proposed LCD DL33458 AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 03/15/2018 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 01/19/2017 Notice Period End Date 03/06/2017 Printed on 6/5/2018. Page 1 of 18

2 The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2016 are trademarks of the American Dental Association. UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Title XVIII of the Social Security Act, 1862 (a)(1)(a) allows coverage and payment for only those services that are conred to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1862 (a)(1)(d) states no payment can be made for services that are for research or experimentation. Title XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. CMS Internet-Only Manual, Pub , Medicare Benefit Policy Manual, Chapter 15, , Approved use of drug CMS Internet-Only Manual, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, 160.1, Induced lesions of nerve tracts Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Chemodenervation refers to the use of chemical agents to produce neuromuscular blockade for the purpose of selective weakening of specific muscles, or muscle groups. This policy applies to the use of neurotoxins as well as other chemical agents used for this purpose. Botulinum toxin, a neurotoxin produced by clostridium botulinum, produces a clinical effect by blocking the release of neurotransmitters, principally acetylcholine, from nerve endings. There are currently four botulinum neurotoxins available in the US with different FDA-approved indication(s): three distinct serotype A botulinum toxin therapeutic products, onabotulinumtoxina (BOTOX ), abobotulinumtoxina (DYSPORT ) and incobotulinumtoxina (XEOMIN ), and the serotype B botulinum toxin product, rimabotulinumtoxinb (MYOBLOC ). The FDA-approved labeling for each product states that the potency units of the botulinum toxin products are not interchangeable. Labeling differs from product to product; dosing units are not comparable. It is the physician's responsibility to select the appropriate product and dose in accordance with FDA-approval indications for use, compendia-supported uses, and supported by peer reviewed specific scientific literature. Chemodenervation techniques are indicated/covered for: 1. Chemodenervation of muscle innervated by the facial nerve in the management of blepharospasm or hemifacial spasm. 2. Chemodenervation of cervical spinal muscles in the management of spasmodic torticollis. 3. Chemodenervation of extremity muscles in the management of dystonias, cerebral palsy, upper and lower limb spasticity (see Note: ) and multiple sclerosis Printed on 6/5/2018. Page 2 of 18

3 4. Chemodenervation of extraocular muscles in the management of strabismus. 5. Chemodenervation of the lower esophageal sphincter in the management of achalasia. 6. Chemodenervation of laryngeal muscles in the treatment of adductor spasmodic dysphonia. 7. Chemodenervation of bilateral frontalis, trapezius, temporalis, sternocleidomastoid, and splenius capitis muscles for treatment of chronic tension headache and intractable daily headache. 8. Chemodenervation of procerus and bilateral frontalis, corrugator, occipitalis, temporalis, trapezius, and cervical paraspinal muscle group for the prophylaxis of headaches in adult patients with chronic migraine ( 15 days per month with headache lasting 4 hours a day or longer). Note: Onabotulinamtoxin A (BOTOX ), is the only botulinum toxin product that is FDA-approved for the prophylaxis of headaches in adult patients with chronic migraine ( 15 days per month with headache lasting 4 hours a day or longer). Onabotulinumtoxin A (Botox ) is the only botulinum toxin that is FDA approved for lower limb spasticity in adults. 9. Chemodenervation of sweat glands for the treatment of severe primary hyperhidrosis that is inadequately managed with topical agents. Severe is defined for this purpose as level 3 (sweating barely tolerable/frequently interferes with daily activity) or level 4 (sweating intolerable/always interferes with daily activities) on the Hyperhidrosis Disease Severity Scale (HDSS). 10. Chemodenervation of the internal anal sphincter for the treatment of chronic anal fissure. 11. Chemodenervation of the detrusor urinae muscle for the treatment of over activity associated with a neurologic condition in adults with an inadequate response to anticholinergic treatment and for the 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. 12. Chemodenervation of the parotid and submandibular salivary glands, bilaterally. Limitations Chemodenervation for the treatment of headaches is limited to patients who experience headaches that may result in permanent cerebral dysfunction, or are intractable because the patient cannot tolerate or does not benefit from standard therapies. Candidates for this treatment are patients with: 1. Intractable migraines (with or without aura). 2. Intractable chronic tension-type headache with moderate to severe pain. 3. Chronic daily headaches defined as patients experiencing more than 15 days of headache per month (either migraine or tension-type features). 4. Chronic migraine ( 15 days per month with headache lasting 4 hours a day or longer) (for the prophylaxis of headaches - in adult patients only). Note: Intractable headache is defined as a patient meeting one of the following criteria for treatment (applies only to disease states 1-3, listed above): 1. Failed trials of at least three preventive pharmacologic migraine therapies (e.g. beta-blockers, anticonvulsants, antidepressants) with or without concomitant behavioral and physical therapies, after titration to maximal tolerated doses or have medical contraindications to common therapies or who cannot tolerate common preventative therapies; or 2. Experience chronic daily headaches or recurrent headaches at least twice per month causing disability lasting three or more days per month; or 3. Standard abortive medication is required more than twice per week, or is contraindicated, ineffective or not tolerated. Summary of Evidence Printed on 6/5/2018. Page 3 of 18

4 N/A Analysis of Evidence (Rationale for Determination) N/A Back to Top 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. 999x Not Applicable 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 Not Applicable CPT/HCPCS Codes Group 1 Paragraph: Injection of a chemodenervation agent for the treatment of achalasia is a procedure that should be done by providers with training to treat diseases of the GI tract (e.g. gastroenterologists and surgeons). Refer to the Upper Gastrointestinal Endoscopy and Visualization L34434 LCD for guidelines for the treatment of achalasia. Use CPT codes and in addition to the code for the primary procedure CPT codes 64612, 64615, 64616, 64642, 64643, 64644, 64645, 64646, 64647, 64653, Group 1 Codes: Chemodenervation anal musc Cystoscopy chemodenervation Chemodenerv saliv glands Destroy nerve face muscle Chemodenerv musc migraine Chemodenerv musc neck dyston Chemodener muscle larynx emg Chemodenerv 1 extremity Chemodenerv 1 extrem 1-4 ea Chemodenerv 1 extrem 5/> mus Chemodenerv 1 extrem 5/> ea Printed on 6/5/2018. Page 4 of 18

5 64646 Chemodenerv trunk musc Chemodenerv trunk musc 6/> Chemodenerv eccrine glands Chemodenerv eccrine glands Nervous system surgery Destroy nerve of eye muscle Guide nerv destr elec stim Guide nerv destr needle emg Group 2 Paragraph: HCPCS Codes Group 2 Codes: J0585 Injection,onabotulinumtoxina J0586 Abobotulinumtoxina J0587 Inj, rimabotulinumtoxinb J0588 Incobotulinumtoxin a ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: CPT code 46505; HCPCS codes J0585, J0586, J0587, J0588 Group 1 Codes: ICD-10 Codes K60.0 Acute anal fissure K60.1 Chronic anal fissure K60.2 Anal fissure, unspecified Group 2 Paragraph: CPT Code 52287; HCPCS code J0585 Group 2 Codes: ICD-10 Codes G12.23 Primary lateral sclerosis G12.24 Familial motor neuron disease G12.25 Progressive spinal muscle atrophy G83.4 Cauda equina syndrome N31.0 Uninhibited neuropathic bladder, not elsewhere classified N31.1 Reflex neuropathic bladder, not elsewhere classified N31.8 Other neuromuscular dysfunction of bladder 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 R35.0 Frequency of micturition Printed on 6/5/2018. Page 5 of 18

6 Group 3 Paragraph: CPT code 64611; HCPCS codes J0587, J0585 Group 3 Codes: ICD-10 Codes K11.7 Disturbances of salivary secretion R68.2 Dry mouth, unspecified Group 4 Paragraph: CPT code 64612; HCPCS codes J0585, J0586, J0587, J0588 Group 4 Codes: ICD-10 Codes G24.4 Idiopathic orofacial dystonia G24.5 Blepharospasm G Migraine without aura, intractable, with status migrainosus G Migraine without aura, intractable, without status migrainosus G Migraine with aura, intractable, with status migrainosus G Migraine with aura, intractable, without status migrainosus G Hemiplegic migraine, intractable, with status migrainosus G Hemiplegic migraine, intractable, without status migrainosus G Persistent migraine aura without cerebral infarction, intractable, with status migrainosus G Persistent migraine aura without cerebral infarction, intractable, without status migrainosus G Persistent migraine aura with cerebral infarction, intractable, with status migrainosus G Persistent migraine aura with cerebral infarction, intractable, without status migrainosus G43.B1 Ophthalmoplegic migraine, intractable G43.C1 Periodic headache syndromes in child or adult, intractable G43.D1 Abdominal migraine, intractable G Other migraine, intractable, with status migrainosus G Other migraine, intractable, without status migrainosus G Menstrual migraine, intractable, with status migrainosus G Menstrual migraine, intractable, without status migrainosus G Migraine, unspecified, intractable, with status migrainosus G Migraine, unspecified, intractable, without status migrainosus G Chronic cluster headache, intractable G Chronic tension-type headache, intractable G50.9 Disorder of trigeminal nerve, unspecified G51.3 Clonic hemifacial spasm G51.8 Other disorders of facial nerve G51.9 Disorder of facial nerve, unspecified H Spastic entropion of right upper eyelid H Spastic entropion of right lower eyelid H Spastic entropion of left upper eyelid H Spastic entropion of left lower eyelid H Spastic entropion of unspecified eye, unspecified eyelid Group 5 Paragraph: CPT codes or 64617; HCPCS codes J0585, J0586, J0587, J0588 Printed on 6/5/2018. Page 6 of 18

7 Group 5 Codes: ICD-10 Codes G24.3 Spasmodic torticollis G Migraine without aura, intractable, with status migrainosus G Migraine without aura, intractable, without status migrainosus G Migraine with aura, intractable, with status migrainosus G Migraine with aura, intractable, without status migrainosus G Hemiplegic migraine, intractable, with status migrainosus G Hemiplegic migraine, intractable, without status migrainosus G Persistent migraine aura without cerebral infarction, intractable, with status migrainosus G Persistent migraine aura without cerebral infarction, intractable, without status migrainosus G Persistent migraine aura with cerebral infarction, intractable, with status migrainosus G Persistent migraine aura with cerebral infarction, intractable, without status migrainosus G43.B1 Ophthalmoplegic migraine, intractable G43.C1 Periodic headache syndromes in child or adult, intractable G43.D1 Abdominal migraine, intractable G Other migraine, intractable, with status migrainosus G Other migraine, intractable, without status migrainosus G Menstrual migraine, intractable, with status migrainosus G Menstrual migraine, intractable, without status migrainosus G Migraine, unspecified, intractable, with status migrainosus G Migraine, unspecified, intractable, without status migrainosus G Chronic cluster headache, intractable G Chronic tension-type headache, intractable J38.01 Paralysis of vocal cords and larynx, unilateral J38.02 Paralysis of vocal cords and larynx, bilateral J38.5 Laryngeal spasm M43.6 Torticollis R49.0 Dysphonia Group 6 Paragraph: CPT codes 64642, 64643, 64644, 64645, 64646, 64647; HCPCS codes J0585, J0586, J0587, J0588 Group 6 Codes: ICD-10 Codes G04.1 Tropical spastic paraplegia G11.4 Hereditary spastic paraplegia G24.02 Drug induced acute dystonia G24.09 Other drug induced dystonia G24.1 Genetic torsion dystonia G24.2 Idiopathic nonfamilial dystonia G24.8 Other dystonia G24.9 Dystonia, unspecified G25.89 Other specified extrapyramidal and movement disorders G35 Multiple sclerosis G36.0 Neuromyelitis optica [Devic] G36.1 Acute and subacute hemorrhagic leukoencephalitis [Hurst] G36.8 Other specified acute disseminated demyelination G36.9 Acute disseminated demyelination, unspecified G37.0 Diffuse sclerosis of central nervous system G37.1 Central demyelination of corpus callosum G37.2 Central pontine myelinolysis G37.3 Acute transverse myelitis in demyelinating disease of central nervous system Printed on 6/5/2018. Page 7 of 18

8 ICD-10 Codes G37.4 Subacute necrotizing myelitis of central nervous system G37.5 Concentric sclerosis [Balo] of central nervous system G37.8 Other specified demyelinating diseases of central nervous system G37.9 Demyelinating disease of central nervous system, unspecified G80.0 Spastic quadriplegic cerebral palsy 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 G81.11 Spastic hemiplegia affecting right dominant G81.12 Spastic hemiplegia affecting left dominant G81.13 Spastic hemiplegia affecting right nondominant G81.14 Spastic hemiplegia affecting left nondominant G82.20 Paraplegia, unspecified G82.21 Paraplegia, complete G82.22 Paraplegia, incomplete G82.51 Quadriplegia, C1-C4 complete G82.52 Quadriplegia, C1-C4 incomplete G82.53 Quadriplegia, C5-C7 complete G82.54 Quadriplegia, C5-C7 incomplete G83.0 Diplegia of upper limbs G83.11 Monoplegia of lower limb affecting right dominant G83.12 Monoplegia of lower limb affecting left dominant G83.13 Monoplegia of lower limb affecting right nondominant G83.14 Monoplegia of lower limb affecting left nondominant G83.21 Monoplegia of upper limb affecting right dominant G83.22 Monoplegia of upper limb affecting left dominant G83.23 Monoplegia of upper limb affecting right nondominant G83.24 Monoplegia of upper limb affecting left nondominant G83.31 Monoplegia, unspecified affecting right dominant G83.32 Monoplegia, unspecified affecting left dominant G83.33 Monoplegia, unspecified affecting right nondominant G83.34 Monoplegia, unspecified affecting left nondominant G83.81 Brown-Sequard syndrome G83.82 Anterior cord syndrome I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left dominant I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right nondominant I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left nondominant I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right dominant I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left dominant I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right nondominant I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left nondominant I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left dominant I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right nondominant Printed on 6/5/2018. Page 8 of 18

9 ICD-10 Codes I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left nondominant I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left dominant I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right nondominant I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left nondominant I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right dominant I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left dominant I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right nondominant I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left nondominant I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left dominant I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right nondominant I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left nondominant I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left dominant I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right nondominant I Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left nondominant I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left dominant I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right nondominant I Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left nondominant I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left dominant I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right non-dominant I Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant I Monoplegia of upper limb following cerebral infarction affecting right dominant I Monoplegia of upper limb following cerebral infarction affecting left dominant I Monoplegia of upper limb following cerebral infarction affecting right non-dominant I Monoplegia of upper limb following cerebral infarction affecting left non-dominant I Monoplegia of lower limb following cerebral infarction affecting right dominant I Monoplegia of lower limb following cerebral infarction affecting left dominant I Monoplegia of lower limb following cerebral infarction affecting right non-dominant I Monoplegia of lower limb following cerebral infarction affecting left non-dominant I Hemiplegia and hemiparesis following cerebral infarction affecting right dominant I Hemiplegia and hemiparesis following cerebral infarction affecting left dominant Printed on 6/5/2018. Page 9 of 18

10 ICD-10 Codes I Hemiplegia and hemiparesis following cerebral infarction affecting right non-dominant I Hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant I Monoplegia of upper limb following other cerebrovascular disease affecting right dominant I Monoplegia of upper limb following other cerebrovascular disease affecting left dominant I Monoplegia of upper limb following other cerebrovascular disease affecting right non-dominant I Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant I Monoplegia of lower limb following other cerebrovascular disease affecting right dominant I Monoplegia of lower limb following other cerebrovascular disease affecting left dominant I Monoplegia of lower limb following other cerebrovascular disease affecting right non-dominant I Monoplegia of lower limb following other cerebrovascular disease affecting left non-dominant I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant I Hemiplegia and hemiparesis following other cerebrovascular disease affecting left dominant I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non-dominant I Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant I Monoplegia of upper limb following unspecified cerebrovascular disease affecting right dominant I Monoplegia of upper limb following unspecified cerebrovascular disease affecting left dominant I Monoplegia of upper limb following unspecified cerebrovascular disease affecting right nondominant I Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non-dominant I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right dominant I Monoplegia of lower limb following unspecified cerebrovascular disease affecting left dominant I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right nondominant I Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non-dominant I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right dominant I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left dominant I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right nondominant I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left nondominant M Contracture of muscle, right shoulder M Contracture of muscle, left shoulder M Contracture of muscle, right upper arm M Contracture of muscle, left upper arm M Contracture of muscle, right forearm M Contracture of muscle, left forearm M Contracture of muscle, right hand M Contracture of muscle, left hand M Contracture of muscle, right thigh M Contracture of muscle, left thigh M Contracture of muscle, right lower leg M Contracture of muscle, left lower leg M Contracture of muscle, right ankle and foot M Contracture of muscle, left ankle and foot M62.48 Contracture of muscle, other site M62.49 Contracture of muscle, multiple sites M Other muscle spasm Group 7 Paragraph: Printed on 6/5/2018. Page 10 of 18

11 CPT code 64615; HCPCS code J0585 Group 7 Codes: ICD-10 Codes G Migraine without aura, intractable, with status migrainosus G Migraine without aura, intractable, without status migrainosus G Migraine with aura, intractable, with status migrainosus G Migraine with aura, intractable, without status migrainosus G Hemiplegic migraine, intractable, with status migrainosus G Hemiplegic migraine, intractable, without status migrainosus G Persistent migraine aura without cerebral infarction, intractable, with status migrainosus G Persistent migraine aura without cerebral infarction, intractable, without status migrainosus G Persistent migraine aura with cerebral infarction, intractable, with status migrainosus G Persistent migraine aura with cerebral infarction, intractable, without status migrainosus G Chronic migraine without aura, not intractable, with status migrainosus G Chronic migraine without aura, not intractable, without status migrainosus G Chronic migraine without aura, intractable, with status migrainosus G Chronic migraine without aura, intractable, without status migrainosus G43.A1 Cyclical vomiting, intractable G43.B1 Ophthalmoplegic migraine, intractable G Other migraine, intractable, with status migrainosus G Other migraine, intractable, without status migrainosus G Menstrual migraine, intractable, with status migrainosus G Menstrual migraine, intractable, without status migrainosus G Migraine, unspecified, intractable, with status migrainosus G Migraine, unspecified, intractable, without status migrainosus Group 8 Paragraph: CPT code 64650, 64653, ; HCPCS codes J0585, J0586, J0587, J0588 *64999 to billed only with L and L with chemodenervation. *NOTE- As there is no specific CPT code for exocrine glands, use CPT code when billing for hyperlacrimation. Group 8 Codes: ICD-10 Codes H Epiphora due to excess lacrimation, right lacrimal gland H Epiphora due to excess lacrimation, left lacrimal gland H Epiphora due to excess lacrimation, bilateral lacrimal glands L Primary focal hyperhidrosis, axilla L Primary focal hyperhidrosis, face L Primary focal hyperhidrosis, palms L Primary focal hyperhidrosis, soles L74.52 Secondary focal hyperhidrosis Group 9 Paragraph: CPT code 67345; HCPCS codes J0585, J0586, J0587, J0588 Printed on 6/5/2018. Page 11 of 18

12 Group 9 Codes: ICD-10 Codes H49.01 Third [oculomotor] nerve palsy, right eye H49.02 Third [oculomotor] nerve palsy, left eye H49.03 Third [oculomotor] nerve palsy, bilateral H49.11 Fourth [trochlear] nerve palsy, right eye H49.12 Fourth [trochlear] nerve palsy, left eye H49.13 Fourth [trochlear] nerve palsy, bilateral H49.21 Sixth [abducent] nerve palsy, right eye H49.22 Sixth [abducent] nerve palsy, left eye H49.23 Sixth [abducent] nerve palsy, bilateral H49.31 Total (external) ophthalmoplegia, right eye H49.32 Total (external) ophthalmoplegia, left eye H49.33 Total (external) ophthalmoplegia, bilateral H49.41 Progressive external ophthalmoplegia, right eye H49.42 Progressive external ophthalmoplegia, left eye H49.43 Progressive external ophthalmoplegia, bilateral H Other paralytic strabismus, right eye H Other paralytic strabismus, left eye H Other paralytic strabismus, bilateral H Monocular esotropia, right eye H Monocular esotropia, left eye H Monocular esotropia with A pattern, right eye H Monocular esotropia with A pattern, left eye H Monocular esotropia with V pattern, right eye H Monocular esotropia with V pattern, left eye H Monocular esotropia with other noncomitancies, right eye H Monocular esotropia with other noncomitancies, left eye H50.05 Alternating esotropia H50.06 Alternating esotropia with A pattern H50.07 Alternating esotropia with V pattern H50.08 Alternating esotropia with other noncomitancies H Monocular exotropia, right eye H Monocular exotropia, left eye H Monocular exotropia with A pattern, right eye H Monocular exotropia with A pattern, left eye H Monocular exotropia with V pattern, right eye H Monocular exotropia with V pattern, left eye H Monocular exotropia with other noncomitancies, right eye H Monocular exotropia with other noncomitancies, left eye H50.15 Alternating exotropia H50.16 Alternating exotropia with A pattern H50.17 Alternating exotropia with V pattern H50.18 Alternating exotropia with other noncomitancies H50.21 Vertical strabismus, right eye H50.22 Vertical strabismus, left eye H Intermittent monocular esotropia, right eye H Intermittent monocular esotropia, left eye H50.32 Intermittent alternating esotropia H Intermittent monocular exotropia, right eye H Intermittent monocular exotropia, left eye H50.34 Intermittent alternating exotropia H Cyclotropia, right eye H Cyclotropia, left eye H50.42 Monofixation syndrome H50.43 Accommodative component in esotropia H50.51 Esophoria H50.52 Exophoria H50.53 Vertical heterophoria H50.54 Cyclophoria Printed on 6/5/2018. Page 12 of 18

13 ICD-10 Codes H50.55 Alternating heterophoria H Brown's sheath syndrome, right eye H Brown's sheath syndrome, left eye H50.69 Other mechanical strabismus H Duane's syndrome, right eye H Duane's syndrome, left eye H50.89 Other specified strabismus H51.0 Palsy (spasm) of conjugate gaze H51.11 Convergence insufficiency H51.12 Convergence excess H51.21 Internuclear ophthalmoplegia, right eye H51.22 Internuclear ophthalmoplegia, left eye H51.23 Internuclear ophthalmoplegia, bilateral H51.8 Other specified disorders of binocular movement ICD-10 Codes that DO NOT Support Medical Necessity Group 1 Paragraph: All other ICD-10 codes not listed under ICD-10 Codes that Support Medical Necessity will be denied as not medically necessary. Group 1 Codes: N/A ICD-10 Additional Information Back to Top General Information Associated Information Documentation Requirements Legible documentation to support medical necessity must be present for each date of service billed on the claim. Documentation should include the following elements: Specific botulinum toxin used Dosage of toxin used (including dosage in units per site) A complete description of the site(s) injected A covered diagnosis (however, when a form of botulinum toxin is used for an indication that is not supported by FDA-approval and/or compendia support, a physician statement in the medical record stating the reason(s) why the unsupported form was used is also required) Support of the clinical effectiveness of the injections, noting date of last injection (if applicable) Support for the medical necessity of electromyography or stimulation guidance procedures if performed. Utilization Guidelines Chemodenervation treatment has a variable lasting beneficial effect from twelve to sixteen weeks, following which the procedure may need to be repeated. It is appropriate to inject the lowest clinically effective dose at the greatest feasible interval that results in the desired clinical result. Services performed for excessive frequency are not medically necessary. Frequency is conred excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation. Sources of Information Printed on 6/5/2018. Page 13 of 18

14 N/A Bibliography Assessment: The Clinical Usefulness of Botulinum Toxin-A in Treating Neurologic Disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurol. Neurology. 1990;40(9): Bielamowicz S, Ludlow CL. Effects of Botulinum Toxin on Pathophysiology in Spasmodic Dysphonia. Ann Otol Rhinol Laryngol. 2000;109(2): Binder WJ, Brin MF, Blitzer A, Schoenrock LD, Pogoda JM. Botulinum Toxin Type A (BOTOX) for Treatment of Migraine Headaches: An Open- Label Study. Otolaryngol Head Neck Surg. 2000;123(6): Brashear A, Lew MF, Dykstra DD, et al. Safety and Efficacy of Neurobloc (Botulinum Toxin Type B) in Type A- Responsive Cervical Dystonia. Neurol. 1999;53(7): Brin MF, Lew MF, Adler CH, et al. Safety and Efficacy of Neurobloc (Botulinum Toxin Type B) in Type A- Resistant Cervical Dystonia. Neurol. 1999;53(7): Ceballos-Baumann AO. Evidence Based Medicine in Botulinum Toxin Therapy for Cervical Dystonia. J Neurol. 2001;248(Suppl 1): Cohen LG, Hallett M, Geller BD, Hochberg F. Treatment of Focal Dystonias of the Hand with Botulinum Toxin Injections. J Neurol, Neurosurg & Psychiatry. 1989;52(3): Comella CL, Jankovic J, Brin MF. Use of Botulinum Toxin Type A in the Treatment of Cervical Dystonia. Neurol. 2000;55(12 Suppl 5):S Cullis PA, O Brien CF, Truong DD, Koller M, Villegas TP, Wallace JD. Botulinum Toxin Type B: An Open-Label, Dose Escalation, Safety and Preliminary Efficacy Study in Cervical Dystonia Patients. Adv Neurol. 1998;78: Heckmann M, Ceballos-Baumann AO, Plewig G. Hyperhidrosis Study Group. Botulinum Toxin A for Axillary Hyperhidrosis (Excessive Sweating). N Engl J Med. 2001;344(7): Jankovic J, Brin MF. Therapeutic Uses of Botulinum Toxin. N Engl J Med. 1991;324(17): Keegan DJ, Geerling G, Lee JP, Blake G, Collin JR, Plant GT. Botulinum toxin treatment for hyperlacrimation secondary to aberrant regenerated seventh nerve palsy or salivary gland transplantation. Br J Ophthalmol. 2002;86(1): Kranz G, Shamim EA, Lin PT, Kranz GS, Hallett M. Transcranial Magnetic Brain Stimulation Modulates Blepharospasm: A Randomized Controlled Study. Neurol. 2010;75(16): Lew MF, Adornato BT, Duane DD, et al. Botulinum Toxin Type B: A Double-Blind, Placebo-Controlled, Safety and Efficacy Study in Cervical Dystonia. Neurol. 1997;49(3): Lew MF, Brashear A, Factor S. The Safety and Efficacy of Botulinum Toxin Type B in the Treatment of Patients with Cervical Dystonia: Summary of Three Controlled Clinical Trials. Neurol. 2000;55(12 Suppl 5):S Maria G, Cassetta E, Gui D, Brisinda G, Bentivoglio AR, Albanese A. A Comparison of Botulinum Toxin and Saline for the Treatment of Chronic Anal Fissure. N Engl J Med. 1998;338(4): Naumann M, Lowe NJ, Kumar CR, Hamm H. Hyperhidrosis Clinical Investigators Group. Botulinum Toxin Type A is a Safe and Effective Treatment for Axillary Hyperhidrosis Over 16 Months: A Prospective Study. Arch Dermatol. 2003;139(6): Pasricha PJ, Ravich WJ, Hendix TR, Sostre S, Jones B, Kalloo AN. Intrasphincteric Botulinum Toxin for the Treatment of Achalasia. N Engl J Med. 1995;332(12): Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum Toxin Type A as a Migraine Preventive Treatment. For the BOTOX Migraine Clinical Research Group. Headache. 2000;40(6): Tsui JK, Hayward M, Mak EK, Schulzer M. Botulinum Toxin Type B in the Treatment of Cervical Dystonia: A Pilot Study. Neurol. 1995;45(11): Printed on 6/5/2018. Page 14 of 18

15 Yoshimura DM, Aminoff MJ, Olney RK. Botulinum Toxin Therapy for Limb Dystonias. Neurol. 1992;42(3Pt1): Back to Top Revision History Information Revision History Date 03/15/2018 R18 02/26/2018 R17 10/01/2017 R16 07/07/2017 R15 06/26/2017 R14 Revision History Number Revision History Explanation Under CMS National Coverage Policy deleted the s from the cited Internet-Only Manual references X2. Throughout the LCD punctuation was corrected. Under Coverage Indications, Limitations and/or Medical Necessity #7 corrected the spelling of splenius. Throughout the LCD punctuation was corrected. Under Bibliography author initials were added to the author name WJ Binder and the spelling of the author name Heckmann was corrected. 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. The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added ICD-10 codes G12.23, G12.24 and G These revisions are due to the 2017 Annual ICD-10 Updates. 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. Under ICD-10 Codes That Support Medical Necessity Group 8: Paragraph added the * Note related to CPT code Under ICD-10 Codes That Support Medical Necessity Group 8: Codes added ICD 10 codes H04.211, H04.212, H and L Under Sources of Information and Basis for Decision added Keegan DJ, Geerling G, Lee JP, Blake G, Collin JR, Plant GT. Botulinum toxin treatment for hyperlacrimation secondary to aberrant regenerated seventh nerve palsy or salivary gland transplantation. Br J Ophthalmol. 2002;86(1): Reason(s) for Change Typographical Error Other Change in Affiliated Contract Numbers Revisions Due To ICD-10-CM Code Changes Reconration Request Reconration Request Printed on 6/5/2018. Page 15 of 18

16 Revision History Date 03/07/2017 R13 03/07/2017 R12 12/10/2016 R11 09/29/2016 R10 09/01/2016 R9 07/05/2016 R8 Revision History Number Revision History Explanation Under Coverage Indications, Limitations and/or Medical Necessity-Indication 9 revised the verbiage to read Chemodenervation of sweat glands for the treatment of severe primary hyperhidrosis that is inadequately managed with topical agents. Severe is defined for this purpose as level 3 (sweating barely tolerable/frequently interferes with daily activity) or level 4 (sweating intolerable/always interferes with daily activities) on the Hyperhidrosis Disease Severity Scale (HDSS). Under CPT/HCPCS Codes Group 1: Paragraph added primary procedure CPT codes and to the verbiage Use CPT codes and in addition to the code for the primary procedure CPT codes 64612, 64615, 64616, 64642, 64643, 64644, 64645, 64646, Under Group 1: Codes added CPT codes and Under Group 8: Paragraph added CPT codes and and added the verbiage *64999 to billed only with L and L with chemodenervation. Under Coverage Indications, Limitations and/or Medical Necessity bullet 8, Note and Limitations bullet 4 corrected the verbiage (= 15 days per month with headache lasting 4 hours a day or longer) to now read (&# days per month with headache lasting 4 hours a day or longer). Under Coverage Indications, Limitations and/or Medical Necessity Note bullet 8, Note and Limitations bullet 4 revised the verbiage (= 15 days per month with headache lasting 4 hours a day or longer) to now read (=15 days per month with headache lasting 4 hours a day or longer). Under Note: revised the verbiage Intractable headache is defined as a patient meeting one of the following criteria for treatment to read Intractable headache is defined as a patient meeting one of the following criteria for treatment (applies only to disease states 1-3, listed above). Under ICD-10 Codes that Support Medical Necessity Group 7: Codes removed G83.81 and G83.82 and added these codes to Group 6: Codes (for ). Under CMS National Coverage Policy revised Manuals to now read Manual. Under CPT/HCPCS Codes Group 6: Codes added G83.81 and G83.82 effective for claims for dates of service beginning 09/29/2016. Under CPT/HCPCS Codes Group 7: Codes deleted G83.81 and G83.82 as these codes were moved to Group 6 for chemodenervation of the extremity or trunk. Under Coverage Indications, Limitations and/or Medical Necessity bullet 3 revised the verbiage to read Chemodenervation of extremity muscles in the management of dystonias, cerebral palsy, upper and lower limb spasticity (see Note: ) and multiple sclerosis. Under Note: added the verbiage Onabotulinumtoxin A (Botox ) is the only botulinum toxin that is FDA approved for lower limb spasticity in adults to the end of the sentence. Under ICD-10 Codes that Support Medical Necessity Group 7: Codes added ICD-10 Codes G83.81 and G Under CPT/HCPCS Codes Group 1: Paragraph in the second sentence deleted CPT codes and The verbiage was corrected to now read Use CPT codes and in addition to the code for the primary procedure CPT codes 64612, 64615, 64616, 64642, 64643, 64644, 64645, 64646, and effective on or after October 01, Under CPT/HCPCS Codes Group 1: Paragraph added verbiage related to achalasia. Under CPT/HCPCS Codes Group 1: Codes deleted CPT code Under ICD-10 Codes that Support Medical Necessity deleted Group 1: Paragraph stating CPT code 43201; HCPCS codes J0585, J0586, J0587, J0588 and Group 1: Codes including ICD-10 code K22.0. Reason(s) for Change Typographical Error Revisions Due To ICD-10-CM Code Changes Other Reconration Request Revisions Due To ICD-10-CM Code Changes Revisions Due To CPT/HCPCS Code Changes Revisions Due To CPT/HCPCS Code Changes Revisions Due To ICD-10-CM Code Changes Printed on 6/5/2018. Page 16 of 18

17 Revision History Date Revision History Number Revision History Explanation 01/22/2016 R7 Under Coverage Indications, Limitations and/or Medical Necessity under #3 added upper limb spasticity ; under #8 added *NOTE: Onabotulinamtoxin A (BOTOX ), is the only botulinum toxin product that is FDA-approved for the prophylaxis of headaches in adult patients with chronic migraines (= 15 days per month with headache lasting 4 hours a day or longer) which was moved from the Utilization Section of this policy. Under Limitations made a few grammatical changes; changes the word they in the first paragraph to read the patient and added *NOTE: in front of Intractable headache is defined.. Under Associated Information in the Utilization Guidelines removed the Onabotulinamtoxin A (BOTOX ), is the only botulinum toxin product that is FDA-approved for the prophylaxis of headaches in adult patients with chronic migraines ( 15 days per month with headache lasting 4 hours a day or longer) as stated above. 12/16/2015 R6 10/01/2015 R5 10/01/2015 R4 10/01/2015 R3 10/01/2015 R2 10/01/2015 R1 Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes I69.051, I69.052, I69.053, I69.054, I69.151, I69.152, I69.153, I69.154, I69.251, I69.252, I69.253, I69.254, I69.351, I69.352, I69.353, I69.354, I69.851, I69.852, I69.853, I69.854, I69.951, I69.952, I69.953, I to Group 7 as the drug Dysport (abobotulinumtoxina) HCPCS code J0585 was also approved for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors by the FDA. Under CMS National Coverage Policy revised Section of Pub of CMS Internet-Only Manuals to now read Under CPT/HCPCS Codes the following codes have had descriptor changes for CPT codes 64644, 64645, The change was due to the Annual HCPCS Update, CR 8975, dated 10/24/2014. Under CPT/HCPCS Codes section descriptor changes were made to CPT Codes 64644, and 64647, effective 7/1/2014. Under ICD-10 Codes that Support Medical Necessity added the following ICD-10 codes to Group 8: G43.011, G43.019, G43.111, G43.119, G43.411, G43.419, G43.511, G43.519, G43.611, G43.619, G43.811, G43.819, G43.831, G43.839, G43.911, G43.919, G43.A1, and G43.B1. Reason(s) for Change Public Typographical Error Other (Annual Validation) Automated Edits to Enforce Reasonable & Necessary Requirements Reconration Request Revisions Due To ICD-10-CM Code Changes Other (Maintenance Annual Validation) Automated Edits to Enforce Reasonable & Necessary Requirements Revisions Due To CPT/HCPCS Code Changes Revisions Due To CPT/HCPCS Code Changes Automated Edits to Enforce Reasonable & Necessary Requirements Reconration Request Revisions Due To ICD-10-CM Code Changes Other ( Provider questioning and usage in LCD.) Printed on 6/5/2018. Page 17 of 18

18 Revision History Date Back to Top Revision History Number Revision History Explanation Under CPT/HCPCS Codes, Group 2, paragraph section, added CPT codes and for clarification in LCD. Under Sources of Information and Basis for Decision removed the statement, "The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies from other Medicare contractors, and discussions with appropriate specialists," as this statement was deemed no longer necessary within the text of the LCD. Reason(s) for Change Associated Documents Attachments N/A Related Local Coverage Documents Article(s) A Response to Comments: Chemodenervation LCD(s) DL (MCD Archive Site) Related National Coverage Documents N/A Public Version(s) Updated on 03/09/2018 with effective dates 03/15/ N/A Updated on 12/07/2017 with effective dates 02/26/ /14/2018 Updated on 08/25/2017 with effective dates 10/01/ /25/2018 Updated on 06/08/2017 with effective dates 07/07/ /30/2017 Updated on 05/23/2017 with effective dates 06/26/ /06/2017 Updated on 01/20/2017 with effective dates 03/07/ /25/2017 Updated on 01/13/2017 with effective dates 03/07/ N/A Some older versions have been archived. Please visit the MCD Archive Site to retrieve them. Back to Top Keywords Chemodenervation Read the LCD Disclaimer Back to Top Printed on 6/5/2018. Page 18 of 18