Neighborhood Health Plan RI Dysport Coverage

Coverage Criteria for Dysport (abobotulinumtoxinA)

Universal Criteria

Covered when ALL of the following are met

Universal: Member is at least 18 years of age (unless otherwise noted) AND member is not on concurrent treatment with another botulinum toxin (e.g., incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxinA-lanm)

Age may vary by indication as noted

Cervical Dystonia

Cervical Dystonia covered when ALL of the following are met

Cervical Dystonia: History of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders AND sustained head tilt OR abnormal posturing with limited range of motion in the neck

FDA‑approved indication

Spastic Conditions

Spasticity covered when ALL of the following are met

Spastic Conditions: Member has one of the following: adult upper or lower limb spasticity (e.g., post‑stroke, traumatic brain, or spinal cord injury) OR pediatric upper/lower limb spasticity in members ≥ 2 years OR spasticity of the lower limbs due to multiple sclerosis or Schilder's disease

Includes post‑stroke, traumatic brain, or spinal cord injury etiologies

Chronic Migraine Prophylaxis

Chronic Migraine Prophylaxis covered when ALL of the following are met

Chronic Migraine: Member is utilizing prophylactic intervention modalities (pharmacotherapy, behavioral therapy, or physical therapy) AND has ≥15 headache (tension‑type and/or migraine‑like) days per month for at least 3 months AND has had at least five attacks with migraine features AND on ≥8 days/month for ≥3 months headaches had migraine characteristics OR headaches relieved by a triptan/ergot AND member has failed at least two 8‑week trials of oral preventive medications15 days/month

See policy for examples of migraine‑preventive medications

Sialorrhea associated with Neurological Disorders

Sialorrhea coverage when ALL of the following are met

Sialorrhea: History of troublesome sialorrhea for at least a 3‑month period AND diagnosis of Parkinson's disease OR severe developmental delays OR cerebral palsy3 months

Indication associated with neurologic disorders

Chronic Anal Fissure

Chronic Anal Fissure coverage when ALL of the following are met

Chronic Anal Fissure: Other causes (e.g., Crohn's disease) have been ruled out AND member has failed non‑pharmacologic supportive measures (e.g., sitz baths, fiber/bulking agents) AND member has tried and failed a ≥1 month trial of conventional pharmacologic therapy (e.g., nifedipine, diltiazem, topical nitroglycerin)1 month

Conservative measures required prior to botulinum toxin use

Incontinence due to Neurogenic Detrusor Overactivity

Neurogenic Detrusor Overactivity covered when ALL of the following are met

Neurogenic Detrusor Overactivity: Detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) confirmed by urodynamic testing AND member has failed a ≥1 month trial of two medications from either antimuscarinic (darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) or beta‑adrenergic (mirabegron) classesurodynamic confirmation

Urodynamic confirmation required

Overactive Bladder (OAB)

Overactive Bladder coverage when ALL of the following are met

OAB: Symptoms of urge urinary incontinence, urgency, and frequency AND member has failed a ≥1 month trial of two medications from either antimuscarinic (darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) or beta‑adrenergic (mirabegron) classes1 month

Medication trials required prior to botulinum toxin therapy

Severe Primary Axillary Hyperhidrosis

Severe Primary Axillary Hyperhidrosis covered when ALL of the following are met

Hyperhidrosis: Member has tried and failed a ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium) AND member has medical complications (e.g., skin infections) OR significant functional impairment/impact to activities of daily living or work/social function1 month

Topical therapy trial required

Ventral Hernia (preoperative)

Ventral Hernia (preoperative use) covered when ALL of the following are met

Ventral Hernia: Member has a large ventral hernia with loss of domain or a contaminated ventral hernia AND Dysport is used preoperatively in members scheduled for abdominal wall reconstruction (AWR)

Single‑use 500‑unit allowance for this preoperative indication; preoperative use may not be renewed

Blepharospasm — outcome/clinical improvement expectations

Covered when treatment produces the following clinical improvements appropriate to the indication:

Blepharospasm outcome: Improvement of severity and/or frequency of eyelid spasms

Clinical improvement required for renewal

Cervical dystonia (outcome node)

Cervical dystonia outcomes: Improvement in the severity and frequency of pain AND improvement of abnormal head positioning

Clinical improvement required for renewal

Spasticity (upper and lower limb) (outcome node)

Spasticity: 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)

Both upper and lower limb spasticity use validated scales

Primary axillary hyperhidrosis (outcome node)

Severe primary axillary hyperhidrosis: Significant reduction in spontaneous axillary sweat production AND significant improvement in activities of daily living

Outcome measures expected for renewal

Chronic migraine prophylaxis (outcome node)

Chronic migraine prophylaxis: Significant decrease in number, frequency, and/or intensity of headaches AND improvement in function AND continued utilization of prophylactic modalities (pharmacotherapy, behavioral therapy, physical therapy)

Outcome documentation expected

Sialorrhea (drooling) (outcome node)

Sialorrhea associated with neurological disorders: Significant decrease in saliva production

Outcome documentation expected

Neurogenic detrusor overactivity / Incontinence (outcome node)

Neurogenic detrusor overactivity/incontinence: Significant improvements in weekly frequency of incontinence episodes AND periodic assessment of post‑void residual (PVR) as medically appropriate

Outcome and monitoring documentation required

Overactive bladder (OAB) (outcome node)

Overactive bladder (OAB): Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition AND periodic assessment of post‑void residual (PVR) as medically appropriate

Outcome and monitoring documentation required

Hemifacial spasm (outcome node)

Hemifacial spasm: Decrease in frequency and/or severity of spasm OR decrease in tone and/or improvement in facial asymmetry

Clinical improvement expected

Chronic anal fissure (outcome node)

Chronic anal fissure: Complete healing of the anal fissure OR other listed clinical endpoints as described in the policy

Chunk in source truncates remaining text; policy lists complete healing as primary outcome

Coverage governance — Medicare Part B and CMS guidance

Medicare Part B outpatient drug coverage is governed by CMS guidance and applicable NCDs/LCDs/LCAs

CMS governance: Coverage follows the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50 Drugs and Biologicals AND any applicable NCD, LCD, or LCA documents listed (e.g., A57474, A57715, A52848)

Compliance with CMS policies is required where applicable; additional indications may be covered at plan discretion.

The policy specifies that coverage is authorized for an initial period of 6 months with the potential for renewal for 12 months. However, for the indication of preoperative use in ventral hernia, the policy explicitly states that such treatment may NOT be renewed, and renewal requests for this indication can be denied.

Preoperative administration of Dysport for ventral hernia repair is a one-time preoperative allowance and is not eligible for subsequent renewal. The document states plainly: Ventral hernias — May not be renewed, and renewal requests for this indication should not be expected to be approved.

Medicare Part B outpatient drug coverage is governed by the Medicare Benefit Policy Manual and any applicable NCDs, LCDs, or LCAs. The policy notes that indications not explicitly governed by those CMS determinations may be covered at the discretion of the health plan, subject to compliance with the cited CMS guidance.

Within the sections cited, there are no additional specific exclusions listed beyond those determined by applicable NCDs, LCDs, or LCAs. The policy indicates that any exclusion determinations would be made in reference to those CMS documents rather than in this section.

The policy prohibits concurrent treatment with another botulinum toxin when seeking coverage for Dysport. It requires that the member is not on concurrent treatment with another botulinum toxin (e.g., incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxinA-lanm).

The reviewed chunks do not contain explicit statements labeling any uses as 'not medically necessary.' Instead, the document directs reliance on CMS policy (NCDs/LCDs/LCAs) and the plan's clinical criteria to determine coverage and potential denials.

Coding, Supply, and Dosing Information

Formulation / supply limits (NDC)NDC

15054-0530-xx	Dysport 300 unit Injection - 1 vial per 84 day supply
15054-0500-xx	Dysport 500 unit Injection - 3 vials per 84 day supply; 1 vial once for Ventral Hernia only

Covered HCPCS billing units by indicationHCPCS

J0586

Injection, abobotulinumtoxinA, 5 units; 1 billable unit = 5 units - billable units vary by indication per policy dosing limits

HCPCS (J0586)HCPCSCovered

J0586

Injection, abobotulinumtoxinA, 5 units; 1 billable unit = 5 units

NDCsNDCCovered

15054-0530-xx	Dysport 300 unit Injection
15054-0500-xx	Dysport 500 unit Injection

Covered ICD-10 Codes (partial list)ICD-10Covered

G11.4	Hereditary spastic paraplegia
G24.3	Spasmodic torticollis
G24.5	Blepharospasm
G35	Multiple sclerosis
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
G80.0	Spastic quadriplegic cerebral palsy

1–10 of 13

1/2

Covered ICD-10 Codes (continued)ICD-10Covered

G82.20	Paraplegia, unspecified
G82.21	Paraplegia, complete
G82.22	Paraplegia, incomplete
G83.0	Diplegia of upper limbs
I69.031	Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side
I69.332	Monoplegia of upper limb following cerebral infarction affecting left dominant side

Covered ICD-10 Codes (additional indications)ICD-10Covered

I69.941	Monoplegia of lower limb following unspecified cerebrovascular disease affecting right dominant side
K11.7	Disturbances of salivary secretions
K43.9	Ventral hernia without obstruction or gangrene
K60.1	Chronic anal fissure
N31.0	Uninhibited neuropathic bladder
N32.81	Overactive bladder
L74.510	Primary focal hyperhidrosis, axilla
M43.6	Torticollis

CMS LCD/LCA Documents (codes/listings)mixed

A57474	CMS article/LCD references relevant to botulinum toxin coverage - see CMS links
A57715	Jurisdiction-specific LCD/NCD references
A52848	Additional jurisdiction coverage documents

Referenced NCD/LCD/Article documentsmixed

A56472	Medicare Part B covered diagnosis LCD document (Jurisdiction 15)
A57186	Medicare Part B covered diagnosis LCD document (Jurisdiction F)
A57185	Medicare Part B covered diagnosis LCD document (Jurisdiction E)

Additional referenced NCD/LCD documentsmixed

A56646	Medicare Part B covered diagnosis LCD document (Jurisdiction J & M)
A56389	Medicare Part B covered diagnosis LCD document (Jurisdiction J & M)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all indicated uses of this therapy. Providers must obtain approval before initiating treatment to ensure coverage eligibility.

Prior authorization required for all indications listed in Initial Approval Criteria and Dosage/Administration.
Pre-authorization applies to Commercial, Medicare, and Medicaid scopes as specified.

Prior Authorization

Prior Authorization: Indication-Specific Dosing and HCPCS

Prior authorization requests must specify indication-specific dosing and the appropriate HCPCS code. Dosage limits and re-treatment intervals in the Dosage/Administration section will be used to determine medical necessity.

Provide indication-specific dose per treatment session and planned re-treatment interval.
Include HCPCS code J0586 (abobotulinumtoxinA, 5 units). Note: 1 billable unit = 5 units.

Background and Scope

Dysport (abobotulinumtoxinA) is a botulinum toxin A formulation used across multiple neuromuscular and related indications, including cervical dystonia, limb spasticity, chronic migraine prophylaxis, sialorrhea, chronic anal fissure, neurogenic detrusor overactivity/overactive bladder, primary axillary hyperhidrosis, blepharospasm, hemifacial spasm, and preoperative use for ventral hernia. Coverage for these indications is subject to indication-specific clinical criteria and applicable CMS coverage determinations; additional indications may be considered at the plan’s discretion per Medicare guidance.

Definitions and References

inv-61: Definition — concurrent botulinum toxin therapy prohibited

Concurrent botulinum toxin therapyConcurrent treatment with another botulinum toxin (e.g., incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxina-lanm) is prohibited when seeking approval for Dysport

Impact on approvalUse of Dysport while on concurrent botulinum toxin therapy will preclude approval

ScopeApplies to all indications unless otherwise specified

inv-62: Definition — validated measuring tools (e.g., Ashworth Scale, CGI)

Validated measuring toolsClinical scales such as the Ashworth Scale used to assess decrease in muscle tone or resistance

Other examplesPhysician Global Assessment (PGA) and Clinical Global Impression (CGI)

OpenPayer

Dysport (abobotulinumtoxinA) — Coverage Criteria

Coverage Criteria for Dysport (abobotulinumtoxinA)

Coding, Supply, and Dosing Information

Provider Requirements, Prior Authorization, and Documentation

Background and Scope

Definitions and References