Dysport® (abobotulinumtoxinA) — Coverage Criteria
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Defines prior authorization, dosing limits, indications, and renewal criteria for Dysport (abobotulinumtoxinA) for Viva Health members receiving intramuscular, intradetrusor, or intradermal injections.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met:
From Universal Criteria and Initial Approval
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Continuation Therapy / Renewal
Renewal covered when ALL of the following are met:
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Blepharospasm - Continued/Response Criteria
Covered when ALL of the following are met
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Cervical Dystonia - Continued/Response Criteria
Covered when ALL of the following are met
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Upper/Lower Limb Spasticity - Response Criteria
Covered when ALL of the following are met
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Severe Primary Axillary/Palmar Hyperhidrosis - Response Criteria
Covered when ALL of the following are met
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Chronic Migraine Prophylaxis - Response Criteria
Covered when ALL of the following are met
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Sialorrhea associated with Neurological Disorders - Response Criteria
Covered when ALL of the following are met
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Detrusor Overactivity / Overactive Bladder - Response Criteria
Covered when ALL of the following are met
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Hemifacial Spasm - Response Criteria
Covered when ANY of the following are met
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Chronic Anal Fissure - Response Criteria
Covered when ANY of the following are met
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Prior authorization is required for Dysport (abobotulinumtoxinA). Initial prior authorization is valid for 6 months (180 days), and standard renewals are available every 12 months (365 days) thereafter unless the policy specifies otherwise. For the indication of ventral hernia used preoperatively for abdominal wall reconstruction, prior authorization validity may NOT be renewed (preoperative use only) and should be requested only for the documented preoperative period.
Units of Dysport are specific to its preparation and assay method and are not interchangeable with units of other botulinum toxin products. Do not convert Dysport units to units of other botulinum toxin formulations when documenting doses or submitting claims.
Coding and Dosing Limits
| Cervical Dystonia: Billable Units = 200 | Cervical Dystonia, Billable Units = 200. Per # days = 200 every 84 days |
| Chronic Migraine Prophylaxis: Billable Units = 60 | Chronic Migraine Prophylaxis, Billable Units = 60. Per # days = 84 |
| Sialorrhea: Billable Units = 100 | Sialorrhea, Billable Units = 100. Per # days = 84 |
| Chronic Anal Fissure: Billable Units = 60 | Chronic Anal Fissure, Billable Units = 60. Per # days = 84 |
| Blepharospasms: Billable Units = 60 | Blepharospasms, Billable Units = 60. Per # days = 84 |
| Upper Limb Spasticity: Billable Units = 200 | Upper Limb Spasticity, Billable Units = 200. Per # days = 84 |
| Lower Limb Spasticity: Billable Units = 300 | Lower Limb Spasticity, Billable Units = 300. Per # days = 84 |
| Neurogenic Detrusor Overactivity/OAB: Billable Units = 160 | Neurogenic Detrusor Overactivity/OAB, Billable Units = 160. Per # days = 84 |
| Severe Primary Axillary Hyperhidrosis: Billable Units = 100 | Severe Primary Axillary Hyperhidrosis, Billable Units = 100. Per # days = 84 |
| Palmar Hyperhidrosis: Billable Units = 100 | Palmar Hyperhidrosis, Billable Units = 100. Per # days = 168 |
| J0586 | Injection, abobotulinumtoxina, 5 units; 1 billable unit = 5 units |
| 15054-0530-xx | Dysport 300 unit powder for injection; single-dose vial |
| 15054-0500-xx | Dysport 500 unit powder for injection; single-dose vial |
| G11.4 | Hereditary spastic paraplegia |
| G24.3 | Spasmodic torticollis |
| G24.5 | Blepharospasm |
| G35.A | Relapsing-remitting multiple sclerosis |
| G35.B0 | Primary progressive multiple sclerosis, unspecified |
| G35.B1 | Active primary progressive multiple sclerosis |
| G35.B2 | Non-active primary progressive multiple sclerosis |
| G35.C0 | Secondary progressive multiple sclerosis, unspecified |
| G35.C1 | Active secondary progressive multiple sclerosis |
| G35.C2 | Non-active secondary progressive multiple sclerosis |
| G43.719 | Chronic migraine without aura, intractable, with 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 |
| I69.342 | Monoplegia of lower limb following cerebral infarction affecting right dominant side |
| I69.343 | Monoplegia of lower limb following cerebral infarction affecting left dominant side |
| I69.344 | Monoplegia of lower limb following cerebral infarction affecting right 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/hemiplegia following other cerebrovascular disease |
Provider Actions, Documentation, and Billing
Initial PA 6 months; renewals 12 months; age ≥18
Prior authorization is required. Initial prior authorization validity will be provided for 6 months (180 days); standard renewals may be issued every 12 months (365 days) thereafter. Members must generally be at least 18 years of age unless an indication specifies a different minimum age (see indication-specific criteria).
PA required; bill with HCPCS J0586
Prior authorization is required for Dysport administration. Claims/billing should use HCPCS code J0586 (Injection, abobotulinumtoxina, 5 units; 1 billable unit = 5 units) and must conform to the policy's dosing limits and intervals for the indicated condition.
NQTL factors considered for PA
Prior authorization was applied after assessing Non‑Quantitative Treatment Limitation (NQTL) factors including the clinical indication, safety and efficacy, potential for misuse/abuse, and drug cost; these factors informed the decision to require PA.
- NQTL factors considered: Indication (Yes), Safety/efficacy (Yes), Potential for misuse/abuse (No), Cost (Yes)
Follow CMS manuals and applicable NCDs/LCDs/LCAs
For Medicare beneficiaries, follow CMS guidance: the Medicare Benefit Policy Manual and any applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs). Compliance with NCDs/LCDs/LCAs is required where applicable.
- Use CMS Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 as applicable.
- Search the CMS Coverage Database for relevant NCD/LCD/LCA documents.
Document required prior therapy trials and failures
Before approval, document trials and failures of required non‑surgical or pharmacologic therapies specific to the indication (examples provided by indication).
- Severe axillary hyperhidrosis: failed ≥1 month trial of a topical agent.
- Severe palmar hyperhidrosis: failed ≥1 month topical trial and failed iontophoresis.
- Chronic anal fissure: failed non‑pharmacologic measures and ≥1 month trial of conventional pharmacologic therapy.
- NDO/OAB: failed 1+ month trials of two medications from antimuscarinic or beta‑adrenergic classes.
Continue other prophylactic modalities for chronic migraine
For chronic migraine prophylaxis, continue other prophylactic interventions as part of ongoing management when administering Dysport.
- Examples: pharmacotherapy, behavioral therapy, neuromodulation, trigger avoidance, physical therapy.
No explicit step‑therapy algorithm in policy (NQTL assessed)
The policy considered NQTL factors (indication, safety/efficacy, cost) when requiring PA, but it does not prescribe a specific step‑therapy algorithm within the cited policy content.
Document baseline objective migraine severity (HIT‑6, MHD)
For chronic migraine prophylaxis PA requests, include baseline disease severity using an objective measure (e.g., HIT‑6 score or Monthly Headache Days) to document the need for therapy.
- Baseline objective measures: HIT‑6, monthly headache days (MHD), MIDAS, or MPFID.
Record baseline and post‑treatment outcomes with validated tools
Document baseline and post‑treatment outcomes using validated tools appropriate to the indication (examples include HIT‑6, MHD, MIDAS for migraine; Ashworth Scale for spasticity; CGI/Physician Global Assessment where applicable).
- Migraine: HIT‑6, MHD, MIDAS, MPFID and functional improvement.
- Spasticity: Ashworth Scale, CGI, or Physician Global Assessment showing decreased tone.
- Incontinence/OAB: documented change in incontinence frequency and periodic PVR assessment.
Follow cited CMS Local Coverage Articles for botulinum toxin billing
Providers should follow the cited Medicare Local Coverage Articles (LCAs) and billing/coding guidance for botulinum toxin injections when billing claims.
- Several LCAs are cited (see references) with effective date 04/09/2026 for billing/coding guidance.
Use covered ICD‑10 codes from Appendix 1 on claims
Use diagnosis codes listed in Appendix 1 for claims. Appendix 1 contains the covered ICD‑10 codes and examples (e.g., G43.* for chronic migraine, I69.* post‑cerebrovascular codes, K60.1 for chronic anal fissure).
- Appendix 1 lists covered ICD‑10 codes that should be used on claims for Dysport.
Denial risk: FDA‑labeled contraindications & concurrent botulinum toxin
Requests may be denied if the member has FDA‑labeled contraindications (e.g., hypersensitivity to any botulinum toxin product or excipients, hypersensitivity to cow's milk protein, active infection at the proposed injection site) or if the member is receiving concurrent treatment with another botulinum toxin.
Denial trigger: insufficient objective outcome documentation
Authorization requests lacking the policy‑specified objective outcome documentation for the condition (e.g., improvement in eyelid spasm for blepharospasm, reduction in monthly headache days or HIT‑6/MIDAS improvement for chronic migraine, validated spasticity scale improvement for spasticity) may be denied.
- Denials may be triggered by absence of documented symptomatic or objective improvement per indication‑specific response criteria.
PA consideration: indication, safety/efficacy, cost
Prior authorization may be applied because of the drug's indication, safety/efficacy considerations, and its cost, per the NQTL factor assessment.
Dual coding required for primary G/M diagnosis codes
Claims using primary G and M diagnosis codes without the required secondary G or I code may be denied; ensure dual‑coding requirements are met when submitting claims with primary G/M codes.
- Primary G and M codes require a secondary G or I code to be payable.
Background
Dysport (abobotulinumtoxinA) is administered by intramuscular, intradetrusor, or intradermal injection and is used for multiple neurologic and non‑neurologic indications. Common clinical uses include treatment of cervical dystonia, upper and lower limb spasticity (including pediatric spasticity), blepharospasm, hemifacial spasm, chronic migraine prophylaxis, sialorrhea associated with neurologic disorders, severe primary axillary or palmar hyperhidrosis, neurogenic detrusor overactivity/overactive bladder, chronic anal fissure, and select preoperative applications such as temporary abdominal muscle relaxation for ventral hernia repair. Coverage under this policy defines prior authorization, indication‑specific dosing limits, and renewal criteria for these intramuscular, intradetrusor, and intradermal uses.
Definitions and Notes
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