CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Cmp_Xeomin_M_20250625.Medical

Defines coverage, quantity limits, indication-specific clinical criteria, dosing, renewal rules, billing codes, and applicable ICD-10 diagnosis codes for Xeomin across Medicaid (pharmacy benefit for Medicaid effective 2022-01-01), Commercial and Medicare scopes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Cmp_Xeomin_M_20250625.Medical

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2022

Next Review Date

Key ActionSubmit documentation demonstrating indication-specific criteria (e.g., urodynamic testing for neurogenic detrusor overactivity, headache frequency logs for chronic migraine, prior trials and failures of listed therapies, age where applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

11Primary Covered Indications Listed

J0588Primary HCPCS Code

3NDC strengths listed

ExtensiveICD-10 codes enumerated

Coverage Summary

Scope: Coverage applies to Medicaid (pharmacy benefit for Medicaid effective 01/01/2022), Commercial, and Medicare members. Overall coverage stance: covered_with_criteria. The policy defines coverage, quantity limits, indication-specific clinical criteria, dosing, renewal rules, billing codes, and applicable ICD-10 diagnosis codes for Xeomin. Medicare determinations (NCD/LCD/LCA) supersede the plan criteria where applicable. Policy adoption and rationale reflect Neighborhood Health Plan of Rhode Island P&T Committee intent to align use with FDA labeling and relevant literature. Effective date: 2022-01-01; Last review: 2025-06.

Initial Therapy Criteria

Universal Initial Criteria

Coverage provided when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age (unless otherwise noted)
Patient is not on concurrent treatment with another botulinum toxin (e.g., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxina-lanm, etc.)

Indication-specific Initial Criteria

Covered when ALL of the following indication-specific criteria are met:

One of the covered indications

Cervical Dystonia
- Patient has a history of recurrent involuntary contraction of one or more muscles in the neck
- AND one of
  - Patient has sustained head tilt
  - Patient has abnormal posturing with limited range of motion in the neck
Spastic Conditions
- Patient has one of the following:
- ANY of the following
  - Upper limb spasticity in adults (used post-stroke for spasms)
  - Pediatric upper limb spasticity in patients aged 2 to 17 years, excluding spasticity caused by cerebral palsy
Prophylaxis for Chronic Migraines
- Patient is utilizing prophylactic intervention modalities (e.g., pharmacotherapy, behavioral therapy, physical therapy, etc.)
- Patient has 15 or more headache (tension-type-like and/or migraine-like) days per month for at least 3 months
- Patient has had at least five attacks with features consistent with migraine (with and/or without aura)
- AND on at least 8 days/month for ≥3 months
  - Headaches have characteristics and symptoms consistent with migraine
  - Patient's suspected migraines are relieved by a triptan or ergot derivative medication
Incontinence due to Neurogenic Detrusor Overactivity
- Patient has detrusor overactivity associated with a neurologic condition confirmed by urodynamic testing
- Patient has failed a ≥1 month trial of two medications from either antimuscarinic or beta-adrenergic classes (examples provided)
Overactive Bladder (OAB)
- Patient has symptoms of urge urinary incontinence, urgency, and frequency
- Patient has failed a ≥1 month trial of two medications from either antimuscarinic or beta-adrenergic classes (examples provided)
Severe Primary Axillary Hyperhidrosis
- Patient has tried and failed ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium, etc.)
- ANY of the following
  - Patient has a history of medical complications such as skin infections or significant functional impairments
  - 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/social gatherings)
Chronic Sialorrhea
- Patient has a history of troublesome sialorrhea for at least a 3-month period
- ANY of the following
  - Patient has Parkinson's disease, atypical Parkinsonism, stroke, or traumatic brain injury
  - Patient has a severe developmental delay
  - Patient has cerebral palsy, other genetic or congenital disorders, or traumatic brain injury
- Patient is at least 2 years of age
Ventral Hernia (preoperative use)
- Patient has a large ventral hernia with loss of domain or contaminated ventral hernia
- Used preoperatively in patients scheduled to receive abdominal wall reconstruction (AWR)

Ventnal Hernia preoperative use: Xeomin is used injected into abdominal muscles 2-4 weeks prior to abdominal wall reconstruction (AWR); single-use 500 units; may not be renewed. See Provider Actions / Quantity limits block for dosing and quantity limits (medical benefit and HCPCS unit limits).

Continuation / Renewal Criteria

Renewal Criteria

Coverage renewal requires ALL of the following:

ALL of the following

Patient continues to meet universal and indication-specific criteria in Initial Criteria
Absence of unacceptable toxicity from the drug (examples: signs of toxin spread such as asthenia, diplopia, ptosis, dysphagia, dysphonia, dysarthria, breathing difficulties; corneal ulceration, etc.)
AND disease response as evidenced by indication-specific improvements
- Blepharospasms: Improvement of severity and/or frequency of eyelid spasms
- Cervical dystonia: Improvement in severity and frequency of pain and improvement of abnormal head positioning
- Upper limb spasticity: Decrease in tone/resistance based on validated tools (e.g., Ashworth Scale, CGI)
- Severe primary axillary hyperhidrosis: Significant reduction in spontaneous axillary sweat production and improvement in activities of daily living
- Prophylaxis for chronic migraines: Significant decrease in number/frequency/intensity of headaches, improvement in function, and continued use of prophylactic modalities
- Incontinence due to detrusor overactivity: Significant improvements in weekly frequency of incontinence episodes and periodic assessment of post-void residual (PVR) as appropriate
- Overactive bladder: Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition and periodic assessment of PVR as appropriate
- Sialorrhea: Significant decrease in saliva production
- Ventral hernia: May not be renewed

Unproven / Exclusions

Exclusions / non-renewable use: Ventral hernia preoperative use may not be renewed. Universal criteria prohibit concurrent treatment with another botulinum toxin (e.g., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxina-lanm, etc.). No additional explicit exclusions are specified in the brief beyond the non-renewal for ventral hernia and the concurrent-toxin prohibition.

Applicable Codes

HCPCS (drug billing)HCPCSCovered

J0588

Injection, incobotulinumtoxinA, 1 unit; 1 billable unit = 1 unit

NDCsNDC

00259-1605-xx	Xeomin 50 unit Injection
00259-1610-xx	Xeomin 100 unit Injection
00259-1620-xx	Xeomin 200 unit Injection

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

G24.3	Spasmodic torticollis
G24.5	Blepharospasm
G25.89	Other specified extrapyramidal and movement disorders
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
G80.0	Spastic quadriplegic cerebral palsy

1–10 of 96

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Provider Actions & Billing Rules

Prior Authorization

Prior authorization and duration

Coverage provided for an initial 6-month authorization and may be renewed for 12 months. Preoperative use in Ventral Hernia may NOT be renewed. For Medicaid pharmacy benefit, limit to 1 fill per 84 days; medical benefit quantity limits apply per HCPCS units and indications.

Documentation Required

Clinical documentation required

Submit clinical documentation demonstrating the indication-specific criteria: urodynamic testing confirming detrusor overactivity for neurogenic detrusor overactivity; headache frequency logs showing ≥15 headache days/month for ≥3 months and documentation of failure of two ≥8-week oral prophylactic trials for chronic migraine; documentation of prior trials and failures of listed therapies (e.g., topical agents for axillary hyperhidrosis, antimuscarinic or beta-adrenergic agents for OAB) and age where applicable (e.g., patients ≥2 years for sialorrhea, pediatric upper limb spasticity ages 2–17).

Urodynamic testing for neurogenic detrusor overactivity
Headache frequency logs (≥15 days/month for ≥3 months) and prior oral prophylactic trial documentation (failed ≥2 medications, ≥8 weeks each)
Documentation of prior trials/failures of topical agents for axillary hyperhidrosis
Documentation of failed trials of two medications (≥1 month each) for OAB
Age documentation where applicable (e.g., ≥2 years for sialorrhea; 2–17 years for pediatric upper limb spasticity)

Billing Rule

HCPCS billing and units

Report J0588 per unit (1 billable unit = 1 unit). Adhere to indication-specific maximum units per treatment interval. Note dual-coding requirement: primary G and M codes require a secondary G or I code to be payable.

J0588 billed per unit (1 unit = 1 billable unit)
Follow indication-specific max units/intervals
Primary G/M codes require secondary G/I code for payment

Billing Rule

Quantity limits (Medical Benefit)

Quantity limits by vial strength under the medical benefit: Xeomin 50-unit injection — 1 vial per 84 days; Xeomin 100-unit injection — 1 vial per 84 days (100-unit: per 112 days for severe primary axillary hyperhidrosis); Xeomin 100-unit injection — 5 vials once for Ventral Hernia (single preoperative use); Xeomin 200-unit injection — 2 vials per 84 days. For Medicaid pharmacy benefit: 1 fill per 84 days (effective 01/01/2022).

Xeomin 50 unit: 1 vial per 84 days
Xeomin 100 unit: 1 vial per 84 days (112 days for severe primary axillary hyperhidrosis)
Xeomin 100 unit: 5 vials once (Ventral Hernia preoperative use only)
Xeomin 200 unit: 2 vials per 84 days
Medicaid pharmacy: 1 fill per 84 days (effective 01/01/2022)

Billing Rule

Max HCPCS units per indication per interval

Maximum HCPCS billable units and associated intervals by indication: Cervical dystonia — 200 units per 84 days; Blepharospasm — 100 units per 84 days; Upper limb spasticity — 400 units per 84 days; Chronic migraine prophylaxis — 200 units per 84 days; Neurogenic detrusor overactivity — 200 units per 84 days; Overactive bladder (OAB) — 100 units per 84 days; Severe primary axillary hyperhidrosis — 100 units per 112 days; Sialorrhea — 100 units per 112 days; Ventral Hernia (preoperative) — 500 units (no interval/N/A; single use).

Cervical dystonia: 200 units / 84 days
Blepharospasm: 100 units / 84 days
Upper limb spasticity: 400 units / 84 days
Chronic migraine: 200 units / 84 days
Neurogenic detrusor overactivity: 200 units / 84 days
Overactive bladder (OAB): 100 units / 84 days
Severe primary axillary hyperhidrosis: 100 units / 112 days
Sialorrhea: 100 units / 112 days
Ventral Hernia (preoperative): 500 units (single use; Per # days = N/A)

Clinical Evidence & References

Evidence summary: The brief cites the Xeomin package insert (Merz Group Services GmbH, December 2024) and notes multiple randomized, double-blind, placebo-controlled trials and guideline references demonstrating efficacy across indications (e.g., reductions in symptom severity using uSFR, GICS, Ashworth Scale, TWSTRS, JRS scores). The package insert (December 2024) is the primary cited reference.

Background

Background: The policy was adopted by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics Committee to align Xeomin use with FDA labeling and relevant clinical literature. Medicare criteria (NCD/LCD/LCA) supersede plan criteria when applicable. Medicaid coverage for Xeomin moved to the pharmacy benefit effective 01/01/2022.

Medicare Determinations

Medicare determinations: The brief lists multiple LCD/LCA entries that may apply and may supersede plan criteria. Entries include: "Billing and Coding: Chemodenervation" (A56646), "Billing and Coding: Botulinum Toxins" (A52848), "Billing and Coding: Botulinum Toxin Type A & B" (A57474), "Billing and Coding: Botulinum Toxin Types A and B Policy" (A57185), "Billing and Coding: Botulinum Toxins" (A56472), "Billing and Coding: Botulinum Toxin Types A and B" (A57186), and "Billing and Coding: Upper Gastrointestinal Endoscopy and Visualization" (A56389). Medicare guidance and applicable NCD/LCD/LCA documents may supersede the plan where applicable.

Revision History

2022-01-01policy_effective

Medicaid coverage moved to the pharmacy benefit effective 01/01/2022; policy effective date for Medicaid Pharmacy scope and Medical scope noted as 01/01/2022.

2025-06last_reviewLatest

Policy last reviewed in 06/2025 (most recent review date).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Cmp_Xeomin_M_20250625.Medical

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2022

Next Review Date

SourceLink

On This Page

Patient has failed at least an 8-week trial of any two oral medications for prevention of migraines (examples provided in policy)