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Dysport® (abobotulinumtoxinA)

Policy Number: PH-0239

 

Intramuscular/Intradetrusor/Intradermal

 

Last Review Date: 05/04/2023

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, 08/2015, 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, 09/2019, 10/2019, 01/2020, 05/2020, 08/2020, 05/2021, 05/2022, 05/2023

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

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.

  1. Length of Authorization 37
  • Coverage will be provided for 6 months and may be renewed.
  • Preoperative use in Ventral Hernia may NOT be renewed.
  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • Dysport 300 unit single-dose vial for injection: 1 vial per 84 day supply
  • Dysport 500 unit single-dose vial for injection: 3 vials per 84 day supply
  • Dysport 500 unit single-dose vial for injection: 1 vial once (for Ventral Hernia only)

B. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units

Per # days

Cervical Dystonia

200

84

Chronic Migraine Prophylaxis

60

84

Sialorrhea

100

84

Chronic Anal Fissure

60

84

Blepharospasms

60

84

 Adult Upper Limb Spasticity

200

84

 Pediatric Upper Limb Spasticity

160

112

 Adult Lower Limb Spasticity

300

84

 Pediatric Lower Limb Spasticity

200

84

Neurogenic Detrusor Overactivity/OAB

160

84

Severe Primary Axillary Hyperhidrosis

100

84

Hemifacial Spasms

60

84

Ventral Hernia

100

N/A

  1.  Initial Approval Criteria 1

Coverage is provided in the following conditions:

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

Universal Criteria 1

  • Patient does not have a hypersensitivity to any botulinum toxin product; AND
  • Patient does not have a hypersensitivity to cow’s milk protein; AND
  • Patient does not have an active infection at the proposed injection site; AND
  • Patient evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
  • Patient is not on concurrent treatment with another botulinum toxin (i.e., incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, etc.); AND  

Cervical Dystonia † Ф 1,28

  • 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

Spastic Conditions † 1,2,12-14,28,40

  • Patient has one of the following:
    • Upper/Lower Limb Spasticity in adults (i.e., spasticity post-stroke, traumatic brain or spinal cord injuries)
    • Upper/Lower Limb Spasticity in pediatric patients at least 2 years of age
    • Spasticity of the lower limbs due to multiple sclerosis or Schilder’s disease

Blepharospasms ‡ Ф 2,9-11

Prophylaxis for Chronic Migraines ‡ 3,22,39,41,42

  • Patient is utilizing prophylactic intervention modalities (i.e. avoiding migraine triggers, pharmacotherapy, behavioral therapy, or 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
          • On at least 8 days per month for > 3 months:
  • Headaches have characteristics and symptoms consistent with migraine§; OR
  • Patient suspected migraines are relieved by a triptan or ergot derivative medication; AND
  • Patient has failed at least an 8-week trial of any two oral medications for the prevention of migraines (see list of migraine-prophylactic medications below for examples ±) prior to initiation of abobotulinumtoxinA

Sialorrhea associated with Neurological Disorders ‡ 4,5

  • Patient has a history of troublesome sialorrhea for at least a 3-month period; AND
    • Patient has Parkinson’s disease; OR
    • Patient has severe developmental delays; OR
    • Patient has cerebral palsy

Chronic Anal Fissure ‡ 6-8

  • 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 (e.g. oral/topical nifedipine, diltiazem, and/or topical nitroglycerin, bethanechol, etc.)

Incontinence due to Neurogenic Detrusor Overactivity ‡ 15-17,23,36

  • 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) ‡ 15-17,23,36

  • 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 Primary Axillary Hyperhidrosis ‡ 18,19,43

  • Patient has tried and failed ≥ 1 month trial of a topical agent (e.g., 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.)

Hemifacial Spasms ‡ 20,21

Ventral Hernia 37,38

  • 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)

FDA approved indication(s); Literature Supported Recommendation; Ф Orphan Drug

± Migraine-Prophylaxis Oral Medications (list not all-inclusive) 25,26,30

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

§ Migraine Features 30,39,41

Migraine without aura

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

Migraine with aura

  • At least two attacks have the following:
  • One or more of the following fully reversible aura symptoms:
    • Visual
    • Sensory
    • Speech and/or language
    • Motor
    • Brainstem
    • Retinal; AND
  • At least three of the following characteristics:
  • At least one aura symptom spreads gradually over ≥5 minutes
  • Two or more symptoms occur in succession
  • Each individual aura symptom lasts 5 to 60 minutes
  • At least one aura symptom is unilateral
  • At least one aura symptom is positive (e.g., scintillations and pins and needles)
  • The aura is accompanied, or followed within 60 minutes, by headache
  1. Renewal Criteria 1-38

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 (e.g., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties, etc.), serious hypersensitivity reactions (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea, etc.); AND
  • Disease response as evidenced by the following:

Blepharospasms 2,9-11

  • Improvement of severity and/or frequency of eyelid spasms

Cervical Dystonia 1

  • Improvement in the severity and frequency of pain; AND
  • Improvement of abnormal head positioning

Upper/Lower Limb Spasticity 1

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

Severe Primary Axillary Hyperhidrosis 18,19

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

Prophylaxis for Chronic Migraines 24,30,39

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

Sialorrhea associated with Neurological Disorders 4,5

  • Significant decrease in saliva production

Incontinence due to Detrusor Overactivity 15-17,23

  • Significant improvements in weekly frequency of incontinence episodes; AND
  • Patient’s post-void residual (PVR) periodically assessed as medically appropriate

Overactive Bladder (OAB) 15-17.23

  • Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition; AND
  • Patient’s post-void residual (PVR) periodically assessed as medically appropriate

     Hemifacial Spasms 20,21

  • 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

  Chronic Anal Fissure 6-8

  • Complete healing of anal fissure; OR
  • Symptomatic improvement of persistent fissures

   Ventral Hernias 37,38

  • May not be renewed
  1. Dosage/Administration 1-4,6-8,15-17,19,20,37

Indication

Dose

Cervical Dystonia

Initial dose: 500 units divided among the affected muscles. 

Re-treatment: 250-1000 units every 12 weeks or longer as necessary

Upper Limb Spasticity

Adults

500-1000 units divided among the affected muscles every 12-16 weeks or longer, as necessary.

Maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 units.

Pediatrics

Up to 8-16 units/kg divided among the affected muscles every 16 weeks, or longer, as necessary. Maximum dose per treatment session for upper limb spasticity is 16 units/kg or 640 units, whichever is lower.

Maximum recommended total dose per treatment session for spasticity in pediatric patients is 30 units/kg or 1000 units in a 3-month interval, whichever is lower.

Chronic Migraine Prophylaxis

Up to 240 units divided among the affected muscles every 12 weeks

Sialorrhea

Up to 450 units divided among the affected muscles every 12 weeks

Chronic Anal Fissure

Up to 150 units divided among the affected muscles every 12 weeks

Lower Limb Spasticity

Adults

1000-1500 units divided among the affected muscles every 12-16 weeks.

Maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 units.

Pediatrics

Up to 10-15 units/kg divided among gastrocnemius-soleus complex muscles, per limb, every 12 weeks, or longer, as necessary. Maximum dose per treatment session for lower limb spasticity is 15 units/kg for unilateral lower limb injections, 30 units/kg for bilateral lower limb injections, or 1000 units, whichever is lower.

Maximum recommended total dose per treatment session for spasticity in pediatric patients is 30 units/kg or 1000 units in a 3-month interval, whichever is lower.

Blepharospasms

Up to 120 units per affected eye every 12 weeks

Neurogenic Detrusor Overactivity/ Overactive Bladder (OAB)

Up to 750 units divided among the affected muscles every 12 weeks

Severe Primary Axillary Hyperhidrosis

Up to 200 units per axilla not more often than every 12 weeks

Hemifacial Spasms

Up to 220 units per treatment session based on sites and severity of the spasm. Subsequent injections administered upon recurrence of spasm, every 12 weeks, if needed.

Ventral Hernia

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

Note: Units of Dysport 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.

  1. Billing Code/Availability Information

HCPCS Code:

  • J0586 – Injection, abobotulinumtoxinA, 5 units; 1 billable unit = 5 units         

NDC(s):

  • Dysport 300 unit powder for injection; single-dose vial: 15054-0530-xx
  • Dysport 500 unit powder for injection; single-dose vial: 15054-0500-xx             
  1. References
  1. Dysport [package insert]. Wrexham, UK; Ipsen Biopharm Ltd; January 2023. Accessed April 2023.
  2. 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
  3. Chankrachang S, Arayawichanont A, Poungvarin N, et al. Prophylactic botulinum type A toxin complex (DYSPORT®) for migraine without aura. Headache 2011; 51(1):52-63.
  4. Mancini F, Zangaglia R, Cristina S, et al. Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonism. Move Disord, 2003; 18(6): 685-688
  5. Pal PK, Calne DB, Calne S, Tsui JK. Botulinum toxin A as treatment for drooling saliva in PD. Neurology 2000; 54:244–247.
  6. Brisinda G, Albanese A, Cadeddu F, et al. Botulinum neurotoxin to treat chronic anal fissure: results of a randomized ‘Botox vs. DYSPORT®’ controlled trial. Aliment Pharmacol Ther. 2004; 19:695-701.
  7. Brisinda G, Cadeddu F, Brandara F, Marniga G, and Maria G. Randomized clinical trial comparing botulinum toxin injections with 0.2 percent nitroglycerin ointment for chronic anal fissure. Br J Surg. 2007; 94:162-167.
  8. Jost W.H. and Schrank B. Chronic anal fissures treated with botulinum toxin injections: a dose-finding study with DYSPORT®. Colorectal Disease. 1999; 1:26-28.
  9. Truong D, Comella C, Fernandez HH, et al. Efficacy and safety of purified botulinum toxin type A (Dysport®) for the treatment of benign essential blepharospasm: A randomized, placebo-controlled, phase II trial. Parkinsonism & Related Disorders Volume 14, Issue 5, July 2008, Pages 407–414. doi:10.1016/j.parkreldis.2007.11.003.
  10. Bentivoglio AR, Fasano A, Ialongo T, et al. Fifteen-Year Experience in Treating Blepharospasm with Botox or Dysport: Same Toxin, Two Drugs. Neurotoxicity Research April 2009, Volume 15, Issue 3, pp 224-231. DOI 10.1007/s12640-009-9023-3
  11. Ching-Piao Tsai, Ming-Chang Chiu, Der-Jen Yen, Yuh-Cherng Guo, Chih-Lun Yuan, and Tzu-Chi Lee. Quantitative Assessment of Efficacy of Dysport Botulinum Toxin Type A) in the Treatment of Idiopathic Blepharospasm and Hemifacial Spasm. Acta Neurologica Taiwanica Vol 14 No 2 June 2005
  12. Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000; 68:707–712.
  13. Pittock SJ, Moore AP, Hardiman O, et al. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis 2003; 15:289–300.
  14. Gusev YI, Banach M, Simonow A, et al. Efficacy and safety of botulinum type A toxin in adductor spasticity due to multiple sclerosis. J Musculoskel Pain 2008; 16:175-188.
  15. Ravindra P, Jackson BL, Parkinson RJ. Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox®) or abobotulinumtoxinA (Dysport®) make a difference? BJU International Volume 112, Issue 1, pages 94–99, July 2013. DOI: 10.1111/bju.12028
  16. Frohme C, Varga Z, Olbert P, Schrader AJ, Hofmann R, Hegele A.  [Effects of botulinum toxin type A in the single and repeated treatment of overactive bladder. A prospective analysis]. Der Urologe. Ausg. A[2010, 49(5):639-644] DOI:10.1007/s00120-009-2208-9
  17. Abeywickrama L, Arunkalaivanan A, Quinlan M. Repeated botulinum toxin type A (Dysport®) injections for women with intractable detrusor overactivity: a prospective outcome study. International Urogynecology Journal. May 2014, Volume 25, Issue 5, pp 601-605
  18. Montaser-Kouhsari L, Zartab H, Fanian F, et al. Comparison of intradermal injection with iontophoresis of abobotulinum toxin A for the treatment of primary axillary hyperhidrosis: A randomized, controlled trial. Journal of Dermatological Treatment. Volume 25, Issue 4, 2014. DOI: 10.3109/09546634.2012.739679.
  19. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001; 344:488-493.
  20. Jitpimolmard S, Tiamkao S, & Laopaiboon M: Long term results of botulinum toxin type A (Dysport) in the treatment of hemifacial spasm: a report of 175 cases. J Neurol Neurosurg Psychiatry 1998; 64(6):751-757.
  21. Van Den Bergh P, Francart J, Mourin S, et al: Five-year experience in the treatment of focal movement disorders with low-dose Dysport botulinum toxin. Muscle Nerve 1995; 18(7):720-729.
  22. The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2013 Jul;33(9):629-808.
  23. 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.
  24. Schwedt TJ. Chronic Migraine. BMJ. 2014;348:g1416.
  25. Modi S, Lowder DM. Medications for migraine prophylaxis. Am Fam Physician. 2006 Jan 1; 73(1):72-8.
  26. 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.
  27. The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2013 Jul;33(9):629-808.
  28. 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.
  29. 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
  30. 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.
  31. Haider A, Solish N. Focal hyperhidrosis: diagnosis and management. CMAJ. 2005;172(1):69-75.
  32. 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.
  33. 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
  34. 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.
  35. Stewart DB, Gaertner W, Glasgow S, et al. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum 2017; 60: 7–14.
  36. 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
  37. 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.
  38. 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.
  39. The International Classification of Headache Disorders, 3rd edition (beta version). Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018 Jan;38(1):1-211.
  40. 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.
  41. 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.
  42. Garza I, Schwedt TJ. (2022) Chronic Migraine. In Swanson JW (Ed). UpToDate. Accessed on April 11, 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.
  43. 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
  44. National Government Services, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A52848). Centers for Medicare & Medicaid Services, Inc. Updated on 12/29/2022 with effective date 01/05/2023. Accessed April 2023.
  45. Noridian Administrative Services, 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.
  46. 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.
  47. 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.
  48. 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.
  49. 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.
  50. 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.
  51. 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

G24.5

Blepharospasm

G35

Multiple sclerosis

G37.0

Diffuse sclerosis of central nervous system

G43.709

Chronic migraine without aura, not intractable, without status migrainosus

G43.719

Chronic migraine without aura, intractable, without status migrainosus

G43.701

Chronic migraine without aura, not intractable, with status migrainosus

G43.711

Chronic migraine without aura, intractable, with 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

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, Diplegia (Upper), Paralysis of both 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

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

I69.051

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

I69.151

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

I69.251

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

I69.351

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

I69.851

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

I69.951

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

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

I69.141

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

I69.241

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

I69.341

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

I69.841

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

I69.939

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

K11.7

Disturbances of salivary secretions

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

K60.1

Chronic anal fissure

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

L74.510

Primary focal hyperhidrosis, axilla

M43.6

Torticollis

Dual coding requirements:

  • 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): 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): 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): 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): 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): 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):  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): 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

DYSPORT® (abobotulinumtoxinA) Prior Auth Criteria
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