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Botox® (onabotulinumtoxinA)

Policy Number: PH-0238

 

 

Intramuscular/Intradetrusor/Intradermal

 

Last Review Date: 10/30/2023

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 02/2013, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 04/2019, 07/2019, 09/2019, 12/2019, 01/2020, 05/2020, 08/2020, 03/2021, 05/2021, 05/2022, 05/2023, 11/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  • o Length of Authorization 65
  1. Coverage will be provided for 6 months and may be renewed.
  2. Preoperative use in Ventral Hernia may NOT be renewed.
  • o Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Botox 100 unit powder for injection: 1 vial per 84 days
  • Botox 100 unit powder for injection:  5 vials once (for Ventral Hernia only)
  • Botox 200 unit powder for injection: 2 vials per 84 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units

Per # days

Blepharospasm

200

84

Cervical Dystonia

300

84

Strabismus

100

84

Esophageal Achalasia

100

168

Adult Upper Limb Spasticity

400

84

Adult Lower Limb Spasticity

400

84

Chronic Migraine

200

84

Severe Primary Axillary Hyperhidrosis

100

112

Sialorrhea

100

84

Neurogenic Bladder/Detrusor Overactivity

200

84

Overactive Bladder

100

84

Chronic Anal Fissures

100

84

Palmar Hyperhidrosis

200

168

Pediatric Upper Limb Spasticity

200

84

Pediatric Lower Limb Spasticity

300

84

Laryngeal Dystonia

100

84

Hemifacial Spasms

                                                     

100

84

Oromandibular Dystonia

200

84

Ventral Hernia

500

N/A

Temporomandibular Disorders

100

84

All other indications

400

84

  • o Initial Approval Criteria 1

Coverage is provided in the following conditions:

  1. Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria 1

  1. Patient evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
  2. Patient does not have a hypersensitivity to any botulinum toxin product; AND
  3. Patient does not have an active infection at the proposed injection site; AND
  4. Patient is not on concurrent treatment with another botulinum toxin (i.e., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, etc.); AND  

Blepharospasms † Ф 1

  • Patient is at least 12 years of age
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin)

Cervical Dystonia † Ф 1,44

  • Patient is at least 16 years of age; AND
  • Patient has a history of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders; AND
    • Patient has sustained head tilt; OR
    • Patient has abnormal posturing with limited range of motion in the neck
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin) AND abobotulinumtoxinA (Dysport)

Strabismus † Ф 1

  • Patient is at least 12 years of age

Spastic Conditions 1,22-25,32,33,44,46,49-51,69

  1. Patient has one of the following:
    1. Upper/Lower Limb spasticity in adults (i.e., used post-stroke for spasms)
    2. Pediatric upper limb spasticity in patients at least 2 years of age (i.e., used post-stroke for spasms or for spasms related to cerebral palsy) Ф
    3. Pediatric lower limb spasticity in patients at least 2 years of age
    4. Spasticity due to multiple sclerosis or Schilder’s disease
    5. Acquired spasticity secondary to spinal cord or brain injuries
    6. Spastic Plegic conditions including Monoplegia, Diplegia, Hemiplegia, Paraplegia (including Hereditary spastic paraplegia) and Quadriplegia
    7. Hemifacial Spasm

Upper limb spasticity †

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  • Both incobotulintoxinA (Xeomin) AND abobotulinumtoxinA (Dysport)

Lower limb spasticity (Adults and pediatric patients aged 2 years or greater) †

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  • AbobotulinumtoxinA (Dysport)

Pediatric upper limb spasticity in patients aged 2 years or greater  †

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  • Both incobotulintoxinA (Xeomin)* AND abobotulinumtoxinA (Dysport)

*when used for spasticity caused by cerebral palsy required trial with Xeomin is waived

Severe Primary Axillary Hyperhidrosis † 1,15,52,59,60,79

  • Patient has tried and failed ≥ 1 month trial of a topical agent (i.e., 20% aluminum chloride, glycopyrronium, aluminum zirconium trichlorohydrate, etc.); AND
    • Patient has a history of medical complications such as skin infections or significant functional impairments; OR
    • Patient has had a significant burden of disease or impact to activities of daily living due to condition (e.g., impairment in work performance/productivity, frequent change of clothing, difficulty in relationships and/or social gatherings, etc.)

Prophylaxis for Chronic Migraines † 1,6,7,53,56,58,75

  • Patient is utilizing prophylactic intervention modalities (i.e., avoiding migraine triggers, pharmacotherapy, behavioral therapy, physical therapy, etc.); AND
  • Patient has a diagnosis of chronic migraines defined as 15 or more headache (tension-type-like and/or migraine-like) days per month for > 3 months; AND
    • Patient has had at least five attacks with features consistent with migraine (with and/or without aura)§; AND
          1. On at least 8 days per month for > 3 months:
  1. Headaches have characteristics and symptoms consistent with migraine§; OR
  2. Patient suspected migraines are relieved by a triptan or ergot derivative medication; AND
  3. Patient has failed at least an 8-week trial of an oral medication for the prevention of migraines (see list of migraine-prophylactic medications below for examples ±) prior to initiation of onabotulinumtoxinA

Patient must have failed or have a contraindication or intolerance to a prophylactic CGRP inhibitor [preferred agents in this category are erenumab (Aimovig) and galcenezumab (Emgality)]. (Note: This criterion excludes PEEHIP members)

Esophageal Achalasia 3-5,68,70

  • Patient is at high risk of complication from pneumatic dilation, surgical myotomy, or peroral endoscopic myotomy (POEM); OR
  • Patient has had treatment failure with pneumatic dilation, surgical myotomy, or POEM; OR
  • Patient has had perforation from pneumatic dilation; OR
  • Patient has an epiphrenic diverticulum or hiatal hernia; OR
  • Patient has esophageal varices

Focal Dystonias 23-25,34-41,71-73

  • Focal upper limb dystonia
  • Patient has functional impairment; OR
  • Patient has pain as a result
  • Laryngeal dystonia
  • Oromandibular dystonia
  • Patient has functional impairment; OR
  • Patient has pain as a result

Sialorrhea associated with Neurological Disorders 16-20,42,43

  • Patient has a history of troublesome sialorrhea for at least a 3 month period; AND
    1. Patient has Parkinson’s disease; OR
    2. Patient has severe developmental delays; OR
      • Patient has cerebral palsy; OR
    3. Patient has amyotrophic lateral sclerosis (ALS)
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin)

Incontinence due to Detrusor Overactivity † 1,55,64,67

  • Patient is at least 5 years of age; AND
  • Patient does not have a current, untreated urinary tract infection; AND
  • Patient has detrusor overactivity associated with a neurologic condition (i.e., spinal cord injury, multiple sclerosis, etc.) that is confirmed by urodynamic testing; AND
  • Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (i.e., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (i.e., mirabegron) classes

Overactive Bladder (OAB) † 1,55

  • Patient does not have a current, untreated urinary tract infection; AND
  • Patient has symptoms of urge urinary incontinence, urgency, and frequency; AND
  • Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium, etc.) or beta-adrenergic (e.g., mirabegron, vibegron, etc.) classes

Severe Palmar Hyperhidrosis ‡ 21,52,74

  • Patient has tried and failed ≥ 1 month trial of a topical agent (i.e., 20% aluminum chloride, etc.); AND
    • Patient has a history of medical complications such as skin infections or significant functional impairments; OR
    • Patient has had a significant impact to activities of daily living due to condition

Chronic Anal Fissure 27-31,47,61-63

  • Other causes of disease have been ruled out (i.e., Crohn’s Disease, etc.); AND
  • Patient has failed on non-pharmacologic supportive measures (i.e., sitz baths, psyllium fiber, bulking agents, etc.); AND
  • Patient has tried and failed a ≥ 1 month trial of conventional pharmacologic therapy (i.e. oral/topical nifedipine, diltiazem, and/or topical nitroglycerin, bethanechol, etc.)

Ventral Hernia 65,66

  • Patient has a large ventral hernia with loss of domain or contaminated ventral hernia; AND
  • Used preoperatively in patients scheduled to receive abdominal wall reconstruction (AWR)

Temporomandibular disorders (TMD)76-78

  • Patient has a diagnosis of TMD with unilateral painful symptoms (i.e., pain upon opening the mouth and chewing, headache, joint clicking/noise, etc.) lasting > 3 months; AND
  • Patient has tried and failed a 3 month trial of conventional noninvasive therapy (i.e., cognitive behavior therapy, pharmacotherapy, physical therapy, occlusal devices, etc.)

FDA Approved Indication; Literature Supported Indication; Ф Orphan Drug

± Migraine-Prophylaxis Oral Medications (list not all-inclusive)6,53,58

  1. Antidepressants (e.g., amitriptyline, fluoxetine, nortriptyline, etc.)
  2. Beta blockers (e.g., propranolol, metoprolol, nadolol, timolol, atenolol, pindolol etc.)
  3. Angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ex. lisinopril, candesartan, etc.)
  4. Anti-epileptics (e.g., divalproex, valproate, topiramate, etc.)
  5. Calcium channels blockers (e.g., verapamil, etc.)

§ Migraine Features 53,58,75

Migraine without aura

  1. At least five attacks have the following:
  2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  3. Headache has at least two of the following characteristics:
    1. Unilateral location
    2. Pulsating quality
    3. Moderate or severe pain intensity
    4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs); AND
  4. During headache at least one of the following:
  5. Nausea and/or vomiting
  6. Photophobia and phonophobia

Migraine with aura

  1. At least two attacks have the following:
  2. One or more of the following fully reversible aura symptoms:
    1. Visual
    2. Sensory
    3. Speech and/or language
    4. Motor
    5. Brainstem
    6. Retinal; AND
  3. At least three of the following characteristics:
  4. At least one aura symptom spreads gradually over ≥5 minutes
  5. Two or more symptoms occur in succession
  6. Each individual aura symptom lasts 5 to 60 minutes
  7. At least one aura symptom is unilateral
  8. At least one aura symptom is positive (e.g., scintillations and pins and needles)
  9. The aura is accompanied, or followed within 60 minutes, by headache
  • o Renewal Criteria 1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and indication specific criteria as identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: symptoms of a toxin spread effect and clinically significant effects with pre-existing neuromuscular disorders (i.e., asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, swallowing/breathing difficulties, etc.), severe hypersensitivity reactions (i.e., anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea, etc.), severe pulmonary effects (i.e., reduced pulmonary function), corneal exposure/ulceration, retrobulbar hemorrhage, bronchitis/upper-respiratory tract infections, autonomic dysreflexia, urinary tract infection, and urinary retention, etc.; AND
  • Disease response as evidenced by the following:

Blepharospasms 1

  1. Improvement of severity and/or frequency of eyelid spasms
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin); OR
  2. There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

Cervical Dystonia 1

  1. Improvement in the severity and frequency of pain; AND
  2. Improvement of abnormal head positioning
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin) AND abobotulinumtoxinA (Dysport); OR
  2. There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

Strabismus 1

  1. Improvement in alignment of prism diopters compared to pre-treatment baseline

Focal Upper/Lower Limb Spasticity 1

  1. Decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (i.e., Ashworth Scale, Physician Global Assessment, Clinical Global Impression (CGI), etc.)

Upper limb spasticity (i.e., used post-stroke for spasms)†

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  1. Both incobotulintoxinA (Xeomin) AND abobotulinumtoxinA (Dysport); OR
  • There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

Lower limb spasticity (i.e., used post-stroke for spasms)†

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  1. AbobotulinumtoxinA (Dysport); OR
  • There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

Pediatric upper limb spasticity in patients aged 2 years or greater †

Patient must have failed or have a contraindication or intolerance to:

  • One or more conventional agents (i.e., benzodiazepine, oral or intrathecal baclofen, etc.); AND
  1. Both incobotulintoxinA (Xeomin)* AND abobotulinumtoxinA (Dysport); OR
  2. There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

*when used for spasticity caused by cerebral palsy required trial with Xeomin is waived

Hemifacial Spasms 32,33,49-51

  1. Decrease in frequency and/or severity of spasm, or a decrease in tone and/or improvement in asymmetry to the affected side of the face

Severe Primary Axillary Hyperhidrosis 1,59

  1. Significant reduction in spontaneous axillary sweat production; AND
  2. Patient has a significant improvement in activities of daily living

Prophylaxis for Chronic Migraines 1,53,56,58

  1. Significant decrease in the number, frequency, and/or intensity of headaches; AND
  2. Improvement in function; AND
  3. Patient continues to utilize prophylactic intervention modalities (i.e., pharmacotherapy, behavioral therapy, physical therapy, etc.)

Esophageal Achalasia 3-5,68,70

  1. Improvement and/or relief in symptoms (i.e., dysphagia, pain, etc. ); OR
  2. Improvement in esophageal emptying as evidenced by functional testing

Focal Dystonias 23-25,34-41,71

  1. Focal upper limb dystonia
    1. Improvement in pain and/or function
  2. Laryngeal dystonia
    1. Improvement in voice function or quality
  3. Oromandibular dystonia
    1. Improvement in pain and function

Sialorrhea associated with Neurological Disorders 16-19,42,43

  1. Significant decrease in saliva production
  1. Patient must have failed or have a contraindication or intolerance to incobotulintoxinA (Xeomin); OR
  2. There is documentation the patient is currently using the requested agent AND is at risk if therapy is changed.

Incontinence due to Detrusor Overactivity 1

  1. Patient does not have a current, untreated urinary tract infection; AND
  2. Significant improvements in weekly frequency of incontinence episodes; AND
  3. Patient’s post-void residual (PVR) periodically assessed as medically appropriate

Overactive Bladder (OAB) 1

  1. Patient does not have a current, untreated urinary tract infection; AND
  2. Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition; AND
  3. Patient’s post-void residual (PVR) periodically assessed as medically appropriate

Severe Palmar Hyperhidrosis 52,74

  1. Significant reduction in spontaneous palmar sweat production; AND
  2. Patient has a significant improvement in activities of daily living

Chronic Anal Fissure 27-31,47,61-63

  1. Complete healing of anal fissure; OR
  2. Symptomatic improvement of persistent fissures

Spastic Conditions, Other (Plegias, etc.) 22-25,32,33,44,46,49-51,69

  1. Decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (i.e., Ashworth Scale, Physician Global Assessment, Clinical Global Impression (CGI), etc.)

Ventral Hernia 65,66

  1. May not be renewed

Temporomandibular Disorders (TMD) 76-78

  1. Patient has significant improvement in symptoms (i.e., pain upon opening the mouth and chewing, headache, joint clicking/noise, etc.)
  • o Dosage/Administration 1,17,21,25,27-30,32,36-38,50,52,65,70,72-74,78

Indication

Dose

Blepharospasm

1.25 to 2.5 Units (0.05 to 0.1 ml per site) injected into each of 3 sites per affected eye every three months. There appears to be little benefit obtainable from injecting more than 5 Units per site. The effect of treatment lasts an average of 12 weeks. Cumulative dose in 30 days should not exceed 200 units.

Cervical Dystonia

198 to 300 Units divided among the affected muscles. No more than 50 Units per site. May re-treat in 12 weeks.

Strabismus

Based on muscle(s) affected, 1.25 to 5 Units in any one muscle initially. Subsequent doses may be increased up to two-fold compared to previously administered dose. No more than 25 Units in any one muscle for recurrent cases. The effect of treatment usually lasts about 12 weeks.

Esophageal Achalasia

100 Units (20 to 25 Units per quadrant) per administration, dose may be repeated in 6 months (24 weeks).

Upper Limb Spasticity

Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, or adverse event history with Botox. For pediatrics, localization of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended.

Adults

  1. In clinical trials, doses ranging from 75 to 400 Units were divided among selected muscles at a given treatment session. Re-treat no sooner than every 12 weeks.

Pediatrics

  1. The recommended dose for treating pediatric upper limb spasticity is 3 Units/kg to 6 Units/kg divided among the affected muscles. The total dose of Botox administered per treatment session in the upper limb should not exceed 6 Units/kg or 200 Units, whichever is lower. The maximum cumulative dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month interval.

Lower Limb Spasticity

Adults

  1. 300 to 400 Units divided among 5 muscle groups (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus). Re-treat no sooner than every 12 weeks.

Pediatrics

  1. The recommended dose for treating pediatric lower limb spasticity is 4 Units/kg to 8 Units/kg divided among the affected muscles. The total dose of Botox administered per treatment session in the lower limb should not exceed 8 Units/kg or 300 Units, whichever is lower. The maximum cumulative dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month interval.

Chronic Migraine

155 Units administered intramuscularly (IM) as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas. The recommended re-treatment schedule is every 12 weeks.

Severe Primary Axillary Hyperhidrosis

50 Units intradermally per axilla every 16 weeks

Sialorrhea

15 to 40 Units in the parotid gland injected in two places and 10 to 15 Units in the submandibular glands (total dose from 50 to 100 Units per patient/administration), repeated in 3 months (12 weeks), if needed.

Neurogenic Bladder/Detrusor Overactivity

Adults

  1. 200 Units per treatment injected into the detrusor muscle using 30 injections (~6.7 Units each).

Pediatrics

  1. Weight ≥ 34 kg: 200 Units per treatment injected into the detrusor muscle using 20 injections.
  2. Weight < 34 kg: 6 Units/kg per treatment injected into the detrusor muscle using 20 injections.

** Re-inject no sooner than 12 weeks from the prior bladder injection.

Overactive Bladder (OAB)

100 Units per treatment injected into the detrusor muscle using 20 injections (5 units each). Re-inject no sooner than 12 weeks from the prior bladder injection.

Palmar Hyperhidrosis

50 to 100 Units per hand, repeated every 6 months (24 weeks), as needed.

Hemifacial Spasms

Recommended dose of 12 to 40 Units, divided among affected muscles. May re-treat every 12 weeks.

Oromandibular Dystonia

80 Units per side (~40 Units injected into both the masseter and submentalis complex muscles) every 12 weeks.

Laryngeal Dystonia

Starting dose of 1.25 to 5 Units into affected muscles. Dose may be titrated up to 25 Units based on response and side effects. Re-treat every 3 months (12 weeks).

Chronic Anal Fissures

Recommended doses of up to 25 Units, injected into the anal sphincter. Re-treat every 3 months (12 weeks).

Ventral Hernia

500 Units divided among abdominal muscles, injected 2-4 weeks prior to AWR surgery. May not be renewed.

Temporomandibular disorders (TMD)

10-40 Units per injection site (masseter muscle, lateral pterygoid muscle, lateral pterygoid muscle, anterior temporalis muscle) for a total of 100 Units every 12 weeks

All other indications (unless otherwise specified)

Not to exceed a cumulative dose of 400 Units (for one or more indications) every 12 weeks.

  • When initiating treatment, the lowest recommended dose should be used.
  • In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 Units, in a 3-month (12-week) interval (unless used for Ventral Hernia).
  • In treating pediatric patients, the total should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month (12-week) interval.
  1. Unless otherwise stated, re-treatment should occur no sooner than 12 weeks from the prior injection.
  2. Units of Botox are specific to the preparation and assay method utilized and are not interchangeable with other preparations of botulinum toxin products and cannot be compared to or converted into units of any other botulinum toxin products
  • o Billing Code/Availability Information

HCPCS Code:

  • J0585 – Injection, onabotulinumtoxinA, 1 unit; 1 billable unit = 1 unit

NDC:

  1. Botox 100 unit powder for injection; single-dose vial: 00023-1145-xx
  2. Botox 200 unit powder for injection; single-dose vial: 00023-3921-xx
  • o References
  1. Botox [package insert].  Irvine, CA; Allergan, Inc; August 2022. Accessed April 2023.
  2. Vaezi MF, Pandolfino JE, Vela MF. ACG Clinical Guideline: Diagnosis and Management of Achalasia. Am J Gastroenterol 2013; 108:1238-49.
  3. Michaela Muller, Alexander J Eckardt, and Till Wehrmann. Endoscopic approach to achalasia. World J Gastrointest Endosc. 2013; 5: 379–390.
  4. Kolbasnik J, Waterfall WE, Fachnie B, Chen Y, Tougas G. Long-term efficacy of botulinum toxin in classical achalasia. Am J Gastroenterol 1999;94:3434-3439
  5. Leyden JE, Moss AC, MacMathuna P. Endoscopic pneumatic dilation versus botulinum toxin injection in the management of primary achalasia. Cochrane Database Syst Rev. 2014; 12:CD005046. PMID 25485740
  6. Modi S, Lowder DM. Medications for migraine prophylaxis. Am Fam Physician. 2006 Jan 1; 73(1):72-8.
  7. Pringheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can Jneurol Sci. 2012 Mar; 39(2 Suppl 2):S1-S9.
  8. Delgado MR, Hirtz D, Aisen M, et al. Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010;74(4):336-43
  9. Quality Standards Subcommittee of the American Academy of Neurology, Practice Committee of the Child Neurology Society, Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review). Report of the Quality Standards Subcommittee of the AAN and Practice Committee of the Child Neurology Society. Neurology 2010 Jan 26; 74(4):336-43.
  10. Simpson DM, Gracies JM, Graham HK, et al. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008 May 6; 70(19):1691-1698.
  11. Koman LA, Mooney JF, Smith BP, et al: Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop 2000; 20(1):108-115
  12. Koman LA, Brashear A, Rosenfeld, et al. Botulinum toxin type A neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy: A multicenter, Open-label Clinical trial. Pediatrics 2001; 108:1062-1071.
  13. Fehlings D, Rang M, Glazier J, et al: An evaluation of botulinum-A toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr 2000; 137(3):331-337
  14. Bjornson K, Hays R, Graubert C, et al. Botulinum toxin for spasticity in children with cerebral palsy: a comprehensive evaluation. Pediatrics. 2007 Jul;120(1):49-58
  15. Naumann M, So Y, Argoff CE, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008 May 6;70(19):1707-14
  16. Lagalla G, Millevolte M, Capecci M, et al. Botulinum toxin type A for drooling in Parkinson’s disease: a double-blind, randomized, placebo-controlled study. Mov Disord 2006;21:704-707
  17. Porta M, Gamba M, Bertacchi G, et al. Treatment of sialorrhea with ultrasound guided botulinum toxin type A injection in patients with neurological disorders. J Neurol Neurosurg Psychiatry 2001;70:538-540
  18. Lipp A, Trottenberg T, Schink T, et al. A randomized trial of botulinum toxin A for treatment of drooling Neurology. 2003;61:1279-1281
  19. Dogu O, Apaydin D, Sevim S, et al. Ultrasound-guided versus 'blind' intraparotid injections of botulinum toxin-A for the treatment of sialorrhoea in patients with Parkinson’s disease. Clin Neurol Neurosurg 2004;106:93–96
  20. Jackson CE, Gronseth G, Rosenfeld J, et al. Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients. Muscle Nerve. 2009;39(2):137
  21. Weinberg T, Solish N, Murray C. Botulinum neurotoxin treatment of palmar and plantar hyperhidrosis. Dermatol Clin. 2014 Oct; 32(4):505-15. Epub 2014 Jul 24
  22. Albanese A, Barnes MP, Bhatia KP, et al. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006;13(5):433-444
  23. Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, de Haan RJ, Speelman JD. Botulinum toxin for writer's cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007;78(3):264-270
  24. Cole R, Hallett M, Cohen LG. Double-blind trial of botulinum toxin for treatment of focal hand dystonia. Mov Disord. 1995 Jul;10(4):466-71. doi: 10.1002/mds.870100411.
  25. 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):355-363
  26. Simpson DM, Blitzer A, Brashear A, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review); Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology May 6, 2008 vol. 70 no. 19 1699-1706
  27. Maria G, Cassetta E, Gui D, et al. A comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N Engl J Med. 1998;338(4):217-220
  28. Mentes BB, Irkorucu O, Akin M, et al: Comparison of botulinum toxin injection and lateral internal sphincterotomy for the treatment of chronic anal fissure. Dis Colon Rectum 2003; 46:232-237
  29. Gui D, Cassetta E, Anastasio G, et al: Botulinum toxin for chronic anal fissure. Lancet 1994; 344:1127-1128
  30. Jost WH & Schimrigk K: Therapy of anal fissure using botulin toxin. Dis Colon Rectum 1994; 37:1321-1324
  31. American Gastroenterological Association. AGA medical position statement: Diagnosis and care of patients with anal fissure. Gastroenterology 2003;123:233-4
  1. Poungvarin N, Viriyavejakul A, & Komoltri C: Placebo-controlled double-blind cross-over study of botulinum A toxin in hemifacial spasm. Parkinsonism Relat Disord 1995; 1(2):85-88
  2. Chen RS, Lu CS, & Tsai CH: Botulinum toxin A injection in the treatment of hemifacial spasm. Acta Neurol Scand 1996; 94(3):207-211
  3. Blitzer A, Brin MF, & Stewart CF: Botulinum toxin management of spasmodic dysphonia (laryngeal dystonia): a 12-year experience in more than 900 patients. Laryngoscope 1998; 108(10):1435-1441
  4. Liu TC, Irish JC, Adams SG, et al: Prospective study of patients' subjective responses to botulinum toxin injection for spasmodic dysphonia. J Otolaryngology 1996; 25:66-74
  5. Blitzer A & Brin MF: Laryngeal dystonia: a series with botulinum toxin therapy. Ann Otol Rhinol Laryngol 1991; 100:85-89
  6. Ludlow CL: Treatment of speech and voice disorders with botulinum toxin. JAMA 1990; 264:2671-2675
  7. Tan EK, Jankovic J. Botulinum toxin A in patients with oromandibular dystonia: long-term follow-up. Neurology 1999;53(9):2102-7
  8. Jankovic J & Hallett M: Neurological Disease and Therapy: Therapy with Botulinum Toxin, 25, M. Dekker, New York, NY, 1994, pp -.
  9. Blitzer A, Brin MF, Greene PE, et al: Botulinum toxin injection for the treatment of oromandibular dystonia. Ann Otol Rhinol Laryngol 1989; 98(2):93-97
  10. Jankovic J, Schwartz K, & Donovan DT: Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry 1990; 53(8):633-639
  11. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004; 62:37-40.
  12. Racette BA, Good L, Sagitto S, Perlmutter JS. Botulinum toxin B reduces sialorrhea in Parkinsonism. Mov Disord. 2003; 18:1059-1061.
  13. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016: 86:1-9.
  14. Egan JV, Baron TH, Adler DG, Davila R, Faigel DO, Gan SL, Hirota WK, Leighton JA, Lichtenstein D, Qureshi WA, Rajan E, Shen B, Zuckerman MJ, Vanguilder T, Fanelli RD, Standards of Practice Committee. Esophageal dilation. Gastrointest Endosc 2006 May; 63(6):755-60.
  15. Oman LA, Mooney JF III, Smith BP, et al. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: A randomized, double-blind, placebo controlled trial. J Pediatr Orthop 2000; 20:108-115.
  16. Perry WB, Dykes SL, Buie WD, Rafferty JF, Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum. 2010 Aug; 53(8):1110-5.
  17. Schwartz S, Cohen S, Dailey S, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009 Sep; 141(3S2):S1-S31.
  18. Cillino S, Raimondi G, Guépratte N, et al. Long-term efficacy of botulinum toxin A for treatment of blepharospasm, hemifacial spasm, and spastic entropion: a multicentre study using two drug-dose escalation indexes. Eye (Lond). 2010 Apr; 24(4):600-7. doi: 10.1038/eye.2009.192.
  19. Defazio G, Abbruzzese G, Girlanda P, et al. Botulinum toxin A treatment for primary hemifacial spasm: a 10-year multicenter study. Arch Neurol. 2002 Mar; 59(3):418-20.
  20. Berardelli A, Formica A, Mercuri B, et al. Botulinum toxin treatment in patients with focal dystonia and hemifacial spasm. A multicenter study of the Italian Movement Disorder Group. Ital J Neurol Sci. 1993 Jun; 14(5):361-7.
  21. Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007 Aug; 33(8):908-23.
  22. The International Classification of Headache Disorders, 3rd edition. Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018; 38(1):1-211.
  23. Garza I, Schwedt TJ. (2022) Chronic Migraine. In Swanson JW (Ed). UpToDate. Accessed on April 6, 2022). Available from https://www.uptodate.com/contents/chronic-migraine?search=chronic%20migraine&source=search_result&selectedTitle=1~68&usage_type=default&display_rank=1.
  24. Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309.
  25. Schwedt TJ. Chronic Migraine. BMJ. 2014;348:g1416.
  26. Glaser DA, Hebert AA, Nast A, et al. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2019;80(1):128. Epub 2018 Jul 10
  27. American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019 Jan;59(1):1-18. doi: 10.1111/head.13456. Epub 2018 Dec 10.
  28. Haider A, Solish N. Focal hyperhidrosis: diagnosis and management. CMAJ. 2005;172(1):69-75.
  29. Nawrocki S, Cha J. The Etiology, Diagnosis and Management of Hyperhidrosis: A Comprehensive Review. Part II. Therapeutic Options. J Am Acad Dermatol. 2019 Jan 30. pii: S0190-9622(19)30167-7.
  30. American Society for Gastrointestinal Endoscopy (ASGE): Standards of practice for the role of endoscopy in patients with anorectal disorders. Gastro Endo. Volume 72, No. 6 : 2010
  31. Wald A, Bharucha AE, Cosman BC, et al. American Gastroenterological Association. American Gastroenterological Association medical position statement: Diagnosis and care of patients with anal fissure. Gastroenterology. 2003;124(1):233.
  32. Stewart DB, Gaertner W, Glasgow S, et al. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum 2017; 60: 7–14.
  33. Kuo HC, Chen SL, Chou CL, et al. Taiwanese Continence Society clinical guidelines for diagnosis and management of neurogenic lower urinary tract dysfunction. Urological Science, Volume 25, Issue 2, 2014, pp. 35-41
  1. Motz BM, Schlosser KA, Heniford BT. Chemical Components Separation: Concepts, Evidence, and Outcomes. Plast Reconstr Surg. 2018 Sep;142(3 Suppl):58S-63S. doi: 10.1097/PRS.0000000000004856.
  2. Elstner KE, Read JW, Saunders J, et al. Selective muscle botulinum toxin A component paralysis in complex ventral hernia repair. Hernia. 2019 Apr 4. doi: 10.1007/s10029-019-01939-3.
  3. Austin PF, Franco I, Dobremez E, et al. OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children. Neurourol Urodyn. 2020 Dec 11;40(1):493–501. doi: 10.1002/nau.24588.
  4. Khashab MA, Vela MF, Thosani N, et al. American Society for Gastrointestinal Endoscopy (ASGE) guideline on the management of achalasia. Gastrointest Endosc. 2020;91(2):213. Epub 2019 Dec 13.
  5. Safarpour Y, Mousavi T, Jabbari B. Botulinum Toxin Treatment in Multiple Sclerosis-a Review. Curr Treat Options Neurol. 2017 Aug 17;19(10):33. doi: 10.1007/s11940-017-0470-5.
  6. Vaezi MF, Pandolfino JE, Yadlapati RH, et al. ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. 2020 Sep;115(9):1393-1411. doi: 10.14309/ajg.0000000000000731.
  7. Albanese A, Asmus F, Bhatia KP, et al. EFNS guidelines on diagnosis and treatment of primary dystonias. Eur J Neurol. 2011 Jan;18(1):5-18. doi: 10.1111/j.1468-1331.2010.03042.x.
  8. Kobayashi T, Niimi S, Kumada M, et al. Botulinum toxin treatment for spasmodic dysphonia. Acta Otolaryngol Suppl. 1993;504:155-7. doi: 10.3109/00016489309128145.
  9. Ludlow CL, Naunton RF, Terada S, et al. Successful treatment of selected cases of abductor spasmodic dysphonia using botulinum toxin injection. Otolaryngol Head Neck Surg. 1991 Jun;104(6):849-55. doi: 10.1177/019459989110400614.
  10. Smith CC, Pariser MD. (2022) Primary focal hyperhidrosis. In Dellavalle RP, Owen C (Eds). UpToDate. Accessed on April 8, 2022). Available from https://www.uptodate.com/contents/primary-focal-hyperhidrosis?search=palmar%20hyperhidrosis&source=search_result&selectedTitle=1~12&usage_type=default&display_rank=1#H706303135.
  11. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153.
  12. Rueda J, Valverde A, Vera A, et al. Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: Uncontrolled Pilot Study. Life (Basel). 2023 Feb; 13(2): 345. Published online 2023 Jan 28. doi: 10.3390/life13020345
  13. Gauer R, Semidey M. Diagnosis and Treatment of Temporomandibular Disorders. Am Fam Physician. 2015;91(6):378-386. https://www.aafp.org/pubs/afp/issues/2015/0315/p378.html
  14. Khawaja S, Scrivani S, Holland N, et al. Effectiveness, Safety, and Predictors of Response to Botulinum Toxin Type A in Refractory Masticatory Myalgia: A Retrospective Study. American Association of Oral and Maxillofacial Surgeons. 0278-2391/17/30116-7. DOI:https://doi.org/10.1016/j.joms.2017.01.031
  15. Mcconaghy J, Fosselma D. Hyperhidrosis: Management Options. Am Fam Physician. 2018;97(11):729-734. https://www.aafp.org/pubs/afp/issues/2018/0601/p729.html#afp20180601p729-b4
  1. National Government Services, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A52848). Centers for Medicare & Medicaid Services, Inc. Updated on 12/22/2022 with effective date 01/05/2023. Accessed April 2023.
  2. Noridian Healthcare Solutions, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B (A57186). Centers for Medicare & Medicaid Services, Inc. Updated on 01/16/2023 with effective date 01/01/2023. Accessed April 2023.
  3. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article: Billing and Coding: Botulinum Toxin Type A & Type B (A57474). Centers for Medicare & Medicaid Services, Inc. Updated on 10/18/2022 with effective date 10/27/2022. Accessed April 2023.
  4. CGS, Administrators, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxins (A56472). Centers for Medicare & Medicaid Services, Inc. Updated on 12/29/2022 with effective date 12/01/2022. Accessed April 2023.
  5. Noridian Healthcare Solutions, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B Policy (A57185). Centers for Medicare & Medicaid Services, Inc. Updated on 01/16/2023 with effective date 01/01/2023. Accessed April 2023.
  6. Palmetto GBA. Local Coverage Article: Billing and Coding: Chemodenervation (A56646). Centers for Medicare & Medicaid Services, Inc. Updated on 01/17/2023 with effective date 01/01/2023. Accessed April 2023.
  7. Palmetto GBA. Local Coverage Article: Billing and Coding: Upper Gastrointestinal Endoscopy and Visualization (A56389). Centers for Medicare & Medicaid Services, Inc. Updated on 01/11/2023 with effective date 01/01/2023. Accessed April 2023.
  8. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A57715). Centers for Medicare & Medicaid Services, Inc. Updated on 02/04/2022 with effective date 02/10/2022. Accessed April 2023.
  9. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A58423). Centers for Medicare & Medicaid Services, Inc. Updated on 02/04/2022 with effective date 02/10/2022. Accessed April 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

G11.4

Hereditary spastic paraplegia

G24.3

Spasmodic torticollis

G24.4

Idiopathic orofacial dystonia

G24.5

Blepharospasm

G24.9

Dystonia, unspecified

G25.89

Other specified extrapyramidal and movement disorders

G35

Multiple sclerosis

G37.0

Diffuse sclerosis of central nervous system

G43.701

Chronic migraine without aura, not intractable, with status migrainosus

G43.709

Chronic migraine without aura, not intractable, without status migrainosus

G43.711

Chronic migraine without aura, intractable, with status migrainosus

G43.719

Chronic migraine without aura, intractable, without status migrainosus

G43.E01

Chronic migraine with aura, not intractable, with status migrainosus

G43.E09

Chronic migraine with aura, not intractable, without status migrainosus

G43.E11

Chronic migraine with aura, intractable, with status migrainosus

G43.E19

Chronic migraine with aura, intractable, without status migrainosus

G51.3

Clonic hemifacial spasm

G51.31

Clonic hemifacial spasm, right

G51.32

Clonic hemifacial spasm, left

G51.33

Clonic hemifacial spasm, bilateral

G51.39

Clonic hemifacial spasm, 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

G81.10

Spastic hemiplegia affecting unspecified side

G81.11

Spastic hemiplegia affecting right dominant side

G81.12

Spastic hemiplegia affecting left dominant side

G81.13

Spastic hemiplegia affecting right nondominant side

G81.14

Spastic hemiplegia affecting left nondominant side

G82.20

Paraplegia, unspecified

G82.21

Paraplegia, complete

G82.22

Paraplegia, incomplete

G82.50

Quadriplegia, unspecified

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

G83.10

Monoplegia of lower limb affecting unspecified side

G83.11

Monoplegia of lower limb affecting right dominant side

G83.12

Monoplegia of lower limb affecting left dominant side

G83.13

Monoplegia of lower limb affecting right nondominant side

G83.14

Monoplegia of lower limb affecting left nondominant side

G83.20

Monoplegia of upper limb affecting unspecified side

G83.21

Monoplegia of upper limb affecting right dominant side

G83.22

Monoplegia of upper limb affecting left dominant side

G83.23

Monoplegia of upper limb affecting right nondominant side

G83.24

Monoplegia of upper limb affecting left nondominant side

G83.4

Cauda equina syndrome

H49.00

Third [oculomotor] nerve palsy, unspecified eye

H49.01

Third [oculomotor] nerve palsy, right eye

H49.02

Third [oculomotor] nerve palsy, left eye

H49.03

Third [oculomotor] nerve palsy, bilateral

H49.10

Fourth [trochlear] nerve palsy, unspecified eye

H49.11

Fourth [trochlear] nerve palsy, right eye

H49.12

Fourth [trochlear] nerve palsy, left eye

H49.13

Fourth [trochlear] nerve palsy, bilateral

H49.20

Sixth [abducent] nerve palsy, unspecified eye

H49.21

Sixth [abducent] nerve palsy, right eye

H49.22

Sixth [abducent] nerve palsy, left eye

H49.23

Sixth [abducent] nerve palsy, bilateral

H49.30

Total (external) ophthalmoplegia, unspecified eye

H49.31

Total (external) ophthalmoplegia, right eye

H49.32

Total (external) ophthalmoplegia, left eye

H49.33

Total (external) ophthalmoplegia, bilateral

H49.40

Progressive external ophthalmoplegia, unspecified eye

H49.41

Progressive external ophthalmoplegia, right eye

H49.42

Progressive external ophthalmoplegia, left eye

H49.43

Progressive external ophthalmoplegia, bilateral

H49.881

Other paralytic strabismus, right eye

H49.882

Other paralytic strabismus, left eye

H49.883

Other paralytic strabismus, bilateral

H49.889

Other paralytic strabismus, unspecified eye

H49.9

Unspecified paralytic strabismus

H50.00

Unspecified esotropia

H50.011

Monocular esotropia, right eye

H50.012

Monocular esotropia, left eye

H50.021

Monocular esotropia with A pattern, right eye

H50.022

Monocular esotropia with A pattern, left eye

H50.031

Monocular esotropia with V pattern, right eye

H50.032

Monocular esotropia with V pattern, left eye

H50.041

Monocular esotropia with other noncomitancies, right eye

H50.042

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

H50.10

Unspecified exotropia

H50.111

Monocular exotropia, right eye

H50.112

Monocular exotropia, left eye

H50.121

Monocular exotropia with A pattern, right eye

H50.122

Monocular exotropia with A pattern, left eye

H50.131

Monocular exotropia with V pattern, right eye

H50.132

Monocular exotropia with V pattern, left eye

H50.141

Monocular exotropia with other noncomitancies, right eye

H50.142

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

H50.21

Vertical strabismus, right eye

H50.22

Vertical strabismus, left eye

H50.30

Unspecified intermittent heterotropia

H50.311

Intermittent monocular esotropia, right eye

H50.312

Intermittent monocular esotropia, left eye

H50.32

Intermittent alternating esotropia

H50.331

Intermittent monocular exotropia, right eye

H50.332

Intermittent monocular exotropia, left eye

H50.34

Intermittent alternating exotropia

H50.40

Unspecified heterotropia

H50.411

Cyclotropia, right eye

H50.412

Cyclotropia, left eye

H50.42

Monofixation syndrome

H50.43

Accommodative component in esotropia

H50.50

Unspecified heterophoria

H50.51

Esophoria

H50.52

Exophoria

H50.53

Vertical heterophoria

H50.54

Cyclophoria

H50.55

Alternating hyperphoria

H50.60

Mechanical strabismus, unspecified

H50.611

Brown's sheath syndrome, right eye

H50.612

Brown's sheath syndrome, left eye

H50.621

Inferior oblique muscle entrapment, right eye

H50.622

Inferior oblique muscle entrapment, left eye

H50.629

Inferior oblique muscle entrapment, unspecified eye

H50.631

Inferior rectus muscle entrapment, right eye

H50.632

Inferior rectus muscle entrapment, left eye

H50.639

Inferior rectus muscle entrapment, unspecified eye

H50.641

Lateral rectus muscle entrapment, right eye

H50.642

Lateral rectus muscle entrapment, left eye

H50.649

Lateral rectus muscle entrapment, unspecified eye

H50.651

Medial rectus muscle entrapment, right eye

H50.652

Medial rectus muscle entrapment, left eye

H50.659

Medial rectus muscle entrapment, unspecified eye

H50.661

Superior oblique muscle entrapment, right eye

H50.662

Superior oblique muscle entrapment, left eye

H50.669

Superior oblique muscle entrapment, unspecified eye

H50.671

Superior rectus muscle entrapment, right eye

H50.672

Superior rectus muscle entrapment,left  eye

H50.679

Superior rectus muscle entrapment, unspecified eye

H50.681

Extraocular muscle entrapment, unspecified, right eye

H50.682

Extraocular muscle entrapment, unspecified, left eye

H50.689

Extraocular muscle entrapment, unspecified, unspecified eye

H50.811

Duane's syndrome, right eye

H50.812

Duane's syndrome, left eye

H50.89

Other specified strabismus

H50.9

Unspecified strabismus

H51.0

Palsy (spasm) of conjugate gaze

H51.11

Convergence insufficiency

H51.12

Convergence excess

H51.20

Internuclear ophthalmoplegia, unspecified eye

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

H51.9

Unspecified disorder of binocular movement

I69.031

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side

I69.032

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left dominant side

I69.033

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right non-dominant side

I69.034

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side

I69.039

Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting unspecified side

I69.041

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right dominant side

I69.042

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left dominant side

I69.043

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right non-dominant side

I69.044

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side

I69.049

Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting unspecified side

I69.051

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side

I69.052

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left dominant side

I69.053

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non-dominant side

I69.054

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side

I69.059

Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting unspecified side

I69.131

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side

I69.132

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left dominant side

I69.133

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right non-dominant side

I69.134

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side

I69.139

Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting unspecified site

I69.141

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right dominant side

I69.142

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left dominant side

I69.143

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right non-dominant side

I69.144

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side

I69.149

Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting unspecified site

I69.151

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant side

I69.152

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left dominant side

I69.153

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right non-dominant side

I69.154

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non-dominant side

I69.159

Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting unspecified side

I69.231

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side

I69.232

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left dominant side

I69.233

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side

I69.234

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side

I69.239

Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting unspecified site

I69.241

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant side

I69.242

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left dominant side

I69.243

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side

I69.244

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side

I69.249

Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting unspecified site

I69.251

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant side

I69.252

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left dominant side

I69.253

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right non-dominant side

I69.254

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant side

I69.259

Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting unspecified side

I69.331

Monoplegia of upper limb following cerebral infarction affecting right dominant side

I69.332

Monoplegia of upper limb following cerebral infarction affecting left dominant side

I69.333

Monoplegia of upper limb following cerebral infarction affecting right non-dominant side

I69.334

Monoplegia of upper limb following cerebral infarction affecting left non-dominant side

I69.339

Monoplegia of upper limb following cerebral infarction affecting unspecified site

I69.341

Monoplegia of lower limb following cerebral infarction affecting right dominant side

I69.342

Monoplegia of lower limb following cerebral infarction affecting left dominant side

I69.343

Monoplegia of lower limb following cerebral infarction affecting right non-dominant side

I69.344

Monoplegia of lower limb following cerebral infarction affecting left non-dominant side

I69.349

Monoplegia of lower limb following cerebral infarction affecting unspecified site

I69.351

Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side

I69.352

Hemiplegia and hemiparesis following cerebral infarction affecting left dominant side

I69.353

Hemiplegia and hemiparesis following cerebral infarction affecting right non-dominant side

I69.354

Hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side

I69.359

Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side

I69.831

Monoplegia of upper limb following other cerebrovascular disease affecting right dominant side

I69.832

Monoplegia of upper limb following other cerebrovascular disease affecting left dominant side

I69.833

Monoplegia of upper limb following other cerebrovascular disease affecting right non-dominant side

I69.834

Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant side

I69.839

Monoplegia of upper limb following other cerebrovascular disease affecting unspecified site

I69.841

Monoplegia of lower limb following other cerebrovascular disease affecting right dominant side

I69.842

Monoplegia of lower limb following other cerebrovascular disease affecting left dominant side

I69.843

Monoplegia of lower limb following other cerebrovascular disease affecting right non-dominant side

I69.844

Monoplegia of lower limb following other cerebrovascular disease affecting left non-dominant side

I69.849

Monoplegia of lower limb following other cerebrovascular disease affecting unspecified site

I69.851

Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant side

I69.852

Hemiplegia and hemiparesis following other cerebrovascular disease affecting left dominant side

I69.853

Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non-dominant side

I69.854

Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant side

I69.859

Hemiplegia and hemiparesis following other cerebrovascular disease affecting unspecified side

I69.931

Monoplegia of upper limb following unspecified cerebrovascular disease affecting right dominant side

I69.932

Monoplegia of upper limb following unspecified cerebrovascular disease affecting left dominant side

I69.933

Monoplegia of upper limb following unspecified cerebrovascular disease affecting right non-dominant side

I69.934

Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non-dominant side

I69.939

Monoplegia of upper limb following unspecified cerebrovascular disease affecting unspecified side

I69.941

Monoplegia of lower limb following unspecified cerebrovascular disease affecting right dominant side

I69.942

Monoplegia of lower limb following unspecified cerebrovascular disease affecting left dominant side

I69.943

Monoplegia of lower limb following unspecified cerebrovascular disease affecting right non-dominant side

I69.944

Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non-dominant side

I69.949

Monoplegia of lower limb following unspecified cerebrovascular disease affecting unspecified side

I69.951

Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right dominant side

I69.952

Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left dominant side

I69.953

Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right non-dominant side

I69.954

Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non-dominant side

I69.959

Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting unspecified side

J38.3

Other diseases of vocal cords

K43.6

Other and unspecified ventral hernia with obstruction, without gangrene

K43.7

Other and unspecified ventral hernia with gangrene

K43.9

Ventral hernia without obstruction or gangrene

K11.7

Disturbances of salivary secretions

K22.0

Achalasia of cardia

K60.1

Chronic anal fissure

L74.510

Primary focal hyperhidrosis, axilla

L74.512

Primary focal hyperhidrosis, palms

M43.6

Torticollis

M26.60

Temporomandibular joint disorder, unspecified

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

Dual coding requirements:

  1. Primary G and M codes require a secondary G or I code in order to be payable

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): 6 & K

NCD/LCD/LCA Document(s): A52848

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52848&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): F

NCD/LCD/LCA Document(s): A57186

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57186&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s):  E

NCD/LCD/LCA Document(s): A57185

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57185&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP   

Jurisdiction(s): 5 & 8

NCD/LCD/LCA Document(s): A57474

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57474&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP   

Jurisdiction(s): 15

NCD/LCD/LCA Document(s): A56472

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56472&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s):  J & M

NCD/LCD/LCA Document(s): A56646

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56646&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): J & M

NCD/LCD/LCA Document(s): A56389

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56389&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): 9; N

NCD/LCD/LCA Document(s): A57715

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57715&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): H & L

NCD/LCD/LCA Document(s): A58423

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a58423&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC